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Trial record 54 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

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ClinicalTrials.gov Identifier: NCT00567164
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Contraception
Ovulation Inhibition
Contraceptives, Oral
Interventions Drug: EE20/DRSP (BAY86-5300)
Drug: EE20/DRSP (YAZ, BAY86-5300)
Enrollment 1887
Recruitment Details The date of first subject, first visit was 22 Oct 2007. The date of last subject, last visit was 11 Nov 2009.
Pre-assignment Details A total of 2450 subjects were screened ; 563 failed screening. The remaining 1887 subjects were assigned to treatment. Of these, 1864 (98.8%) were in the Full Analysis Set (FAS), ie, study medication was dispensed to them and they had at least 1 post-baseline observation. A total of 1196 (63.4%) subjects completed the study.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Period Title: Overall Study
Started 1421 234 232
Subjects Received Treatment 1406 [1] 232 [1] 226 [1]
Completed 875 161 160
Not Completed 546 73 72
Reason Not Completed
Withdrawal by Subject             171             21             17
Protocol Violation             23             4             2
Adverse Event             92             13             9
Death             0             0             1
Lost to Follow-up             202             23             21
Pregnancy             20             4             6
Primary Reason coded as 'Other'             37             8             16
Missing             1             0             0
[1]
Full Analysis Set
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) Total
Hide Arm/Group Description Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected. Total of all reporting groups
Overall Number of Baseline Participants 1406 232 226 1864
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1406 participants 232 participants 226 participants 1864 participants
25.2  (4.5) 26.8  (6.8) 27.3  (6.4) 25.7  (5.2)
[1]
Measure Description: Only describes treated participants
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1406 participants 232 participants 226 participants 1864 participants
Female
1406
 100.0%
232
 100.0%
226
 100.0%
1864
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Only describes treated participants
1.Primary Outcome
Title Pearl Index
Hide Description The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
Overall Number of Participants Analyzed 1406 1638
Mean (95% Confidence Interval)
Unit of Measure: Pregnancies per 100 years of exposure
1.65
(0.96 to 2.65)
1.92
(1.22 to 2.89)
2.Secondary Outcome
Title Number of Bleeding Days (Including Spotting Days)
Hide Description Number of days per participant with bleeding or spotting
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1317 222 207
Mean (Standard Deviation)
Unit of Measure: Days
39.9  (29.6) 46.8  (33.1) 51.8  (34.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300), Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.85
Confidence Interval 95%
-16.3 to -7.394
Parameter Dispersion
Type: Standard Deviation
Value: 30.356
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Bleeding Days (Excluding Spotting Days)
Hide Description Number of days per participant with bleeding (excluding spotting days)
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1317 222 207
Mean (Standard Deviation)
Unit of Measure: Days
19.4  (15.7) 21.4  (15.6) 32.9  (23.5)
4.Secondary Outcome
Title Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.
Hide Description Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.
Time Frame Day 1 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1067 176 169
Mean (Standard Deviation)
Unit of Measure: Days
Including days with spotting 16.6  (12.2) 18.5  (12.9) 19.7  (9.8)
Excluding days with spotting 8.3  (6.9) 9.1  (7.2) 12.6  (6.5)
5.Secondary Outcome
Title Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.
Hide Description Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.
Time Frame Day 91 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 950 161 145
Mean (Standard Deviation)
Unit of Measure: Days
Including days with spotting 11.0  (9.7) 12.5  (10.5) 14.8  (8.0)
Excluding days with spotting 5.1  (5.2) 5.4  (5.5) 9.7  (6.3)
6.Secondary Outcome
Title Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3
Hide Description Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.
Time Frame Day 181 to Day 270
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 863 156 131
Mean (Standard Deviation)
Unit of Measure: Days
Including days with spotting 10.0  (8.7) 11.4  (10.8) 14.8  (8.0)
Excluding days with spotting 4.7  (4.8) 4.9  (5.0) 9.4  (6.5)
7.Secondary Outcome
Title Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4
Hide Description Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.
Time Frame Day 271 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 808 143 112
Mean (Standard Deviation)
Unit of Measure: Days
Including days with spotting 9.0  (9.2) 9.5  (10.3) 13.6  (7.3)
Excluding days with spotting 4.2  (4.8) 4.0  (4.8) 8.4  (5.5)
8.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1124 191 187
Measure Type: Number
Unit of Measure: Percentage of Participants
84.2 83.8 66.8
9.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1025 176 180
Measure Type: Number
Unit of Measure: Percentage of Participants
85.9 84.7 86.7
10.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 868 154 182
Measure Type: Number
Unit of Measure: Percentage of Participants
78.6 79.2 84.6
11.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 601 121 161
Measure Type: Number
Unit of Measure: Percentage of Participants
73.4 66.1 86.3
12.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 368 71 155
Measure Type: Number
Unit of Measure: Percentage of Participants
78.0 69.0 85.8
13.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 229 43 155
Measure Type: Number
Unit of Measure: Percentage of Participants
77.7 69.8 85.2
14.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 129 30 144
Measure Type: Number
Unit of Measure: Percentage of Participants
78.3 70.0 84.0
15.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 78 13 143
Measure Type: Number
Unit of Measure: Percentage of Participants
82.1 69.2 86.7
16.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 46 10 138
Measure Type: Number
Unit of Measure: Percentage of Participants
73.9 80.0 85.5
17.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 19 10 130
Measure Type: Number
Unit of Measure: Percentage of Participants
78.9 70.0 84.6
18.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 9 8 128
Measure Type: Number
Unit of Measure: Percentage of Participants
55.6 62.5 85.9
19.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 4 3 117
Measure Type: Number
Unit of Measure: Percentage of Participants
0 33.3 78.6
20.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13.
Arm/Group Title Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1 73
Measure Type: Number
Unit of Measure: Percentage of Participants
0 20.5
21.Secondary Outcome
Title Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14
Hide Description A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.
Time Frame Up to 1 year
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Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14.
Arm/Group Title Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
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13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Percentage of Participants
9.1
22.Secondary Outcome
Title Number of Intracyclic Bleeding Days
Hide Description Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.
Time Frame Up to 1 year
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Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
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Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1222 208 201
Mean (Standard Deviation)
Unit of Measure: Days
Including spotting only episodes 8.0  (11.8) 14.4  (19.1) 7.1  (12.7)
Excluding spotting only episodes 3.6  (7.9) 7.3  (12.8) 5.2  (11.4)
23.Secondary Outcome
Title Number of Scheduled and Unscheduled Bleeding Days
Hide Description Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.
Time Frame Up to 1 year
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Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)
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Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
Overall Number of Participants Analyzed 1316 222
Mean (Standard Deviation)
Unit of Measure: Days
Scheduled bleeding days 20.6  (14.1) 21.9  (13.9)
Unscheduled bleeding days 20.0  (20.4) 25.3  (27.8)
24.Secondary Outcome
Title Length of Cycles
Hide Description Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.
Time Frame Up to 1 year
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Hide Analysis Population Description
Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included.
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description:
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
Overall Number of Participants Analyzed 1317 222 207
Overall Number of Units Analyzed
Type of Units Analyzed: Cycles
5575 1021 2082
Mean (Standard Deviation)
Unit of Measure: Days
70.9  (41.3) 67.6  (39.1) 28.8  (10.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Hide Arm/Group Description Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
All-Cause Mortality
Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/1406 (0.85%)      6/232 (2.59%)      2/226 (0.88%)    
Gastrointestinal disorders       
Abdominal pain * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis acute * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Infections and infestations       
Acute tonsillitis * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Appendicitis * 1  2/1406 (0.14%)  2 0/232 (0.00%)  0 0/226 (0.00%)  0
Diverticulitis * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Gastroenteritis * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Influenza * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Pneumonia * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Pyelonephritis * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Sepsis * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Urinary tract infection * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Injury, poisoning and procedural complications       
Accident * 1  0/1406 (0.00%)  0 0/232 (0.00%)  0 1/226 (0.44%)  1
Metabolism and nutrition disorders       
Dehydration * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Malignant melanoma * 1  0/1406 (0.00%)  0 1/232 (0.43%)  1 0/226 (0.00%)  0
Thyroid cancer * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1  2/1406 (0.14%)  2 0/232 (0.00%)  0 1/226 (0.44%)  1
Psychiatric disorders       
Depression * 1  1/1406 (0.07%)  1 1/232 (0.43%)  1 0/226 (0.00%)  0
Renal and urinary disorders       
Renal failure * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
Reproductive system and breast disorders       
Pelvic prolapse * 1  1/1406 (0.07%)  1 0/232 (0.00%)  0 0/226 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   330/1406 (23.47%)      68/232 (29.31%)      65/226 (28.76%)    
Infections and infestations       
Nasopharyngitis * 1  83/1406 (5.90%)  95 15/232 (6.47%)  17 13/226 (5.75%)  18
Sinusitis * 1  88/1406 (6.26%)  103 16/232 (6.90%)  17 6/226 (2.65%)  6
Upper respiratory tract infection * 1  93/1406 (6.61%)  102 23/232 (9.91%)  25 27/226 (11.95%)  31
Reproductive system and breast disorders       
Cervical dysplasia * 1  105/1406 (7.47%)  112 21/232 (9.05%)  22 23/226 (10.18%)  28
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
The Flexible (extended) Regimen no. 1 Group was enrolled under slightly different eligibility criteria for age, BMI, and fertility status than the other two treatment groups. This did not affect the results or interpretation of the results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of subgroup data and single center data shall not be performed until the complete study has been published. All relevant aspects regarding publication will be part of the contract between the sponsor and the investigator/institution.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00567164     History of Changes
Other Study ID Numbers: 91698
311642 ( Other Identifier: Bayer )
First Submitted: December 3, 2007
First Posted: December 4, 2007
Results First Submitted: October 7, 2013
Results First Posted: March 12, 2014
Last Update Posted: March 12, 2014