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Trial record 25 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

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ClinicalTrials.gov Identifier: NCT00511797
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : October 4, 2010
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dysmenorrhea
Interventions Drug: SH T04740B
Drug: SH T00186DF
Drug: SH T04740F
Drug: Placebo
Enrollment 249
Recruitment Details  
Pre-assignment Details

Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug. Patients were analyzed as treated.

FAS was the primary analysis set for all efficacy endpoints and safety analyses. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS who did not have major protocol deviations.

Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day placebo for 28 days in each 28-day cycle
Period Title: Overall Study
Started 62 63 62 62
Subjects Dispensed Drugs 61 63 61 59
Subjects Received Treatment 61 [1] 62 [1] 61 [1] 58 [1]
Completed 55 55 51 47
Not Completed 7 8 11 15
Reason Not Completed
Adverse Event             1             2             2             2
Lost to Follow-up             1             0             0             1
Pregnancy             0             0             0             1
Protocol Violation             0             2             2             3
Withdrawal by Subject             3             3             4             2
Never dispensed             1             0             1             3
Study drug not taken             0             1             0             1
Partially missing diary             0             0             1             0
Other (moving etc)             1             0             1             2
[1]
FAS
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo Total
Hide Arm/Group Description 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day placebo for 28 days in each 28-day cycle Total of all reporting groups
Overall Number of Baseline Participants 61 62 61 58 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants 62 participants 61 participants 58 participants 242 participants
31.0
(21 to 45)
30.6
(20 to 43)
30.9
(20 to 48)
30.8
(20 to 44)
30.8
(20 to 48)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 61 participants 58 participants 242 participants
Female
61
 100.0%
62
 100.0%
61
 100.0%
58
 100.0%
242
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Diagnosis type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 61 participants 58 participants 242 participants
Functional dysmenorrhea 47 48 42 41 178
Organic dysmenorrhea 14 14 19 17 64
Details of organic dysmenorrhea   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 61 participants 58 participants 242 participants
Endometriosis 1 3 4 5 13
Uterine fibroids 9 7 10 9 35
Uterine adenomyosis 6 7 11 8 32
Bicornuate uterus 2 0 0 0 2
[1]
Measure Description: Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea.
Average length of menstrual cycle  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 61 participants 62 participants 61 participants 58 participants 242 participants
28.6
(25 to 31)
28.7
(25 to 33)
28.3
(25 to 32)
28.7
(25 to 31)
28.6
(25 to 33)
Body mass index (BMI)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 61 participants 62 participants 61 participants 58 participants 242 participants
21.05
(15.6 to 30.0)
20.41
(16.6 to 25.8)
20.67
(16.4 to 29.9)
21.19
(17.2 to 27.7)
20.82
(15.6 to 30.0)
1.Primary Outcome
Title Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Time Frame Baseline and up to 4 Cycles (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 61 62 61 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.5  (1.52) -2.1  (1.51) -1.9  (1.63) -1.0  (1.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRSP 3 mg/EE 20 μg, Placebo
Comments Three null hypotheses were sequentially tested. H01: DRSP 3 mg >= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg < Placebo (Active is greater in decrease of score), H02: DRSP 2 mg >= Placebo vs H12: DRSP 2 mg < Placebo, H03: DRSP 1 mg >= Placebo vs H13: DRSP 1 mg < Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.49 to -0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.290
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DRSP 2 mg/EE 20 μg, Placebo
Comments Second null hypothesis was tested. H02: DRSP 2 mg >= Placebo vs H12: DRSP 2 mg < Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.10
Confidence Interval 95%
-1.64 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.277
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DRSP 1 mg/EE 20 μg, Placebo
Comments Third null hypotheses was tested. H03: DRSP 1 mg >= Placebo vs H13: DRSP 1 mg < Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.44
Confidence Interval 95%
-2.00 to -0.89
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.280
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Time Frame Baseline and up to 4 Cycles (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 61 62 61 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 -2.4  (1.40) -2.1  (1.49) -1.8  (1.67) -0.8  (1.50)
Cycle 2 -2.1  (1.40) -2.3  (1.57) -1.9  (1.50) -1.1  (1.59)
Cycle 3 -2.5  (1.34) -2.3  (1.52) -2.1  (1.34) -1.0  (1.59)
Cycle 4 -2.5  (1.55) -2.3  (1.41) -2.1  (1.54) -1.0  (1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DRSP 3 mg/EE 20 μg, Placebo
Comments Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-1.74 to -0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.322
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DRSP 2 mg/EE 20 μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.34
Confidence Interval 95%
-1.95 to -0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.306
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DRSP 1 mg/EE 20 μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.53
Confidence Interval 95%
-2.16 to -0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.317
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
Hide Description Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Measure Type: Number
Unit of Measure: participants
none 15 17 11 3
mild 28 27 19 11
moderate 9 7 14 21
severe 3 2 7 11
4.Secondary Outcome
Title Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
Hide Description Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Measure Type: Number
Unit of Measure: participants
none 34 36 30 18
mild 15 12 18 14
moderate 5 4 2 9
severe 1 1 1 5
5.Secondary Outcome
Title Number of Participants With Severity of Headache During Menstruation at Cycle 4
Hide Description Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Measure Type: Number
Unit of Measure: participants
none 47 35 39 29
mild 5 10 5 6
moderate 1 6 3 6
severe 2 2 4 5
6.Secondary Outcome
Title Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
Hide Description Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Time Frame Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Measure Type: Number
Unit of Measure: participants
none 51 47 47 40
mild 2 4 4 4
moderate 2 1 0 2
severe 0 1 0 0
7.Secondary Outcome
Title Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
Hide Description Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Time Frame Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Measure Type: Number
Unit of Measure: participants
0 40 41 42 30
1 11 10 7 6
2 3 2 1 5
3 0 0 0 3
4 0 0 0 1
5 1 0 1 1
6 0 0 0 0
8.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
Hide Description VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame From baseline up to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-43.0  (23.44) -39.5  (22.12) -31.8  (23.55) -10.3  (24.53)
9.Secondary Outcome
Title Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
Hide Description VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Time Frame Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.9  (11.52) 5.4  (11.78) 4.0  (14.26) 11.5  (20.22)
10.Secondary Outcome
Title Change From Baseline in Endometrial Thickness After 4-cycle Treatment
Hide Description Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.
Time Frame From baseline to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 53 53 50 47
Mean (Standard Deviation)
Unit of Measure: mm
-5.5  (4.11) -7.1  (3.25) -6.3  (4.07) -0.1  (2.79)
11.Secondary Outcome
Title Number of Bleeding / Spotting Episodes
Hide Description Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.
Time Frame For the first 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with the defined data)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 59 60 57 56
Mean (Standard Deviation)
Unit of Measure: number of episodes
bleeding / spotting 3.3  (0.9) 3.3  (1.3) 3.4  (0.9) 2.9  (0.9)
bleeding only 0.5  (0.9) 0.4  (0.8) 0.3  (0.5) 0.4  (0.8)
spotting only 0.3  (0.6) 0.4  (1.1) 0.4  (0.8) 0.2  (0.6)
12.Secondary Outcome
Title Number of Bleeding / Spotting Days
Hide Description Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.
Time Frame For the first 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with the defined data)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 59 60 57 56
Mean (Standard Deviation)
Unit of Measure: days
bleeding / spotting 32.3  (8.7) 31.2  (11.4) 29.2  (11.0) 22.6  (5.5)
bleeding only 21.3  (5.9) 19.3  (8.8) 18.6  (6.5) 17.4  (4.9)
spotting only 11.1  (7.0) 11.9  (7.6) 10.5  (8.2) 5.2  (2.5)
13.Secondary Outcome
Title Participants With Withdrawal Bleeding
Hide Description Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Time Frame At Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 55 52 48
Measure Type: Number
Unit of Measure: participants
50 50 49 47
14.Secondary Outcome
Title Participants With Intracyclic Bleeding
Hide Description Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
Time Frame At Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 55 52 48
Measure Type: Number
Unit of Measure: participants
14 8 8 4
15.Secondary Outcome
Title Participants With Non-heavy Intracyclic Bleeding
Hide Description Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Time Frame At Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 14 8 8 4
Measure Type: Number
Unit of Measure: participants
14 8 7 2
16.Secondary Outcome
Title Participants With Non-heavy Withdrawal Bleeding
Hide Description Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Time Frame At Cycle 4 (28 dyas per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 50 50 49 47
Measure Type: Number
Unit of Measure: participants
45 44 42 38
17.Secondary Outcome
Title Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
Hide Description CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Time Frame From baseline to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 55 51 47
Mean (Full Range)
Unit of Measure: Units/L
-2.78
(-26.4 to 5.5)
0.53
(-17.4 to 184.9)
-3.79
(-35.6 to 32.5)
0.89
(-7.8 to 15.8)
18.Secondary Outcome
Title Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
Hide Description CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.
Time Frame From baseline to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 55 51 47
Mean (Full Range)
Unit of Measure: mg/dL
0.015
(-0.31 to 0.85)
0.042
(-0.09 to 0.77)
-0.014
(-2.73 to 0.35)
-0.175
(-7.38 to 0.62)
19.Secondary Outcome
Title Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
Hide Description Estradiol is a predominant sex hormone that presents in female.
Time Frame From baseline to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 55 51 48
Mean (Full Range)
Unit of Measure: pg/mL
-18.32
(-341.5 to 968.9)
-42.23
(-336.8 to 329.0)
-98.02
(-477.8 to 231.2)
49.20
(-182.7 to 310.3)
20.Secondary Outcome
Title Change From Baseline in Serum Progesterone Level at Cycle 4
Hide Description Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.
Time Frame From baseline to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 54 53 50 47
Mean (Full Range)
Unit of Measure: ng/mL
-7.93
(-22.2 to 6.3)
-8.23
(-23.6 to 5.7)
-9.37
(-22.3 to 6.7)
-0.27
(-20.6 to 18.7)
21.Post-Hoc Outcome
Title Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
Hide Description Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Time Frame From baseline to Cycle 4(28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Participants with data at Cycle 4)
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 55 53 51 46
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.1  (1.19) -0.3  (1.12) -0.1  (1.06) 0.1  (1.22)
22.Post-Hoc Outcome
Title Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Time Frame Baseline and up to Cycle 4 (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 61 62 61 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
age: < 30 years -2.2  (1.46) -2.4  (1.50) -1.9  (1.49) -1.2  (1.45)
age: >= 30 years -2.8  (1.54) -1.9  (1.49) -1.9  (1.75) -0.8  (1.60)
weight: < 50 kg -3.0  (1.30) -2.4  (0.99) -1.5  (1.39) -0.7  (1.65)
weight: >= 50kg -2.1  (1.57) -2.0  (1.64) -2.2  (1.74) -1.1  (1.50)
functional dysmenorrhea -2.3  (1.63) -2.1  (1.52) -1.8  (1.73) -1.0  (1.47)
organic dysmenorrhea -2.9  (1.00) -2.1  (1.49) -2.3  (1.37) -1.0  (1.70)
with medical surgical history -2.3  (1.62) -2.0  (1.50) -2.1  (1.61) -1.1  (1.68)
without medical surgical history -2.6  (1.42) -2.3  (1.53) -1.8  (1.66) -0.8  (1.27)
23.Post-Hoc Outcome
Title Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Time Frame Baseline and up to 4 Cycles (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 61 62 61 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
with previous medication -2.5  (1.53) -2.1  (1.51) -1.9  (1.63) -1.0  (1.53)
with pregnancy history -2.7  (1.62) -1.9  (1.32) -2.2  (1.72) -1.0  (2.03)
without pregnancy history -2.3  (1.47) -2.2  (1.62) -1.8  (1.61) -1.0  (1.22)
with birth history -2.9  (1.59) -2.1  (1.28) -2.3  (1.96) -1.1  (2.00)
without birth history -2.3  (1.49) -2.1  (1.62) -1.9  (1.55) -1.0  (1.35)
total dysmenorrheal score at baseline: 3 or 4 -2.1  (1.28) -1.9  (1.36) -1.8  (1.44) -1.0  (1.49)
total dysmenorrheal score at baseline: 5 or 6 -3.4  (1.75) -2.6  (1.77) -2.4  (2.06) -1.1  (1.65)
24.Post-Hoc Outcome
Title Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication
Hide Description Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Time Frame Baseline and up to 4 Cycles (28 days per cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects without previous medication in DRSP 1 mg/EE 20 μg group was 1, so the standard deviation was not measurable. The number of subjects without previous medication in the other three groups were 0, so the data were not applicable.
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description:
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1 tablet per day placebo for 28 days in each 28-day cycle
Overall Number of Participants Analyzed 1 0 0 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Hide Arm/Group Description 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle 1 tablet per day placebo for 28 days in each 28-day cycle
All-Cause Mortality
DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/62 (1.61%)      2/63 (3.17%)      0/62 (0.00%)      1/62 (1.61%)    
Infections and infestations         
Appendicitis * 1  0/62 (0.00%)  0 1/63 (1.59%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lipoma * 1  0/62 (0.00%)  0 0/63 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Cervix carcinoma stage 0 * 1  0/62 (0.00%)  0 1/63 (1.59%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Skin and subcutaneous tissue disorders         
Henoch-Schonlein purpura * 1  1/62 (1.61%)  1 0/63 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DRSP 1 mg/EE 20 μg DRSP 2 mg/EE 20 μg DRSP 3 mg/EE 20 μg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/62 (90.32%)      58/63 (92.06%)      60/62 (96.77%)      53/62 (85.48%)    
Gastrointestinal disorders         
Abdominal pain lower * 1  5/62 (8.06%)  5 7/63 (11.11%)  10 9/62 (14.52%)  10 3/62 (4.84%)  4
Abdominal pain upper * 1  2/62 (3.23%)  6 5/63 (7.94%)  6 1/62 (1.61%)  1 1/62 (1.61%)  1
Constipation * 1  4/62 (6.45%)  5 2/63 (3.17%)  2 3/62 (4.84%)  3 1/62 (1.61%)  2
Nausea * 1  16/62 (25.81%)  28 18/63 (28.57%)  32 22/62 (35.48%)  31 17/62 (27.42%)  30
General disorders         
Malaise * 1  2/62 (3.23%)  3 4/63 (6.35%)  4 3/62 (4.84%)  4 0/62 (0.00%)  0
Immune system disorders         
Seasonal allergy * 1  4/62 (6.45%)  5 2/63 (3.17%)  2 4/62 (6.45%)  4 5/62 (8.06%)  5
Infections and infestations         
Nasopharyngitis * 1  17/62 (27.42%)  24 24/63 (38.10%)  35 24/62 (38.71%)  32 26/62 (41.94%)  32
Injury, poisoning and procedural complications         
Post procedural haemorrhage * 1  8/62 (12.90%)  8 8/63 (12.70%)  8 8/62 (12.90%)  9 8/62 (12.90%)  8
Procedural pain * 1  3/62 (4.84%)  3 2/63 (3.17%)  2 4/62 (6.45%)  4 3/62 (4.84%)  3
Investigations         
Blood triglycerides increased * 1  5/62 (8.06%)  5 1/63 (1.59%)  1 3/62 (4.84%)  3 0/62 (0.00%)  0
Prothrombin time shortened * 1  0/62 (0.00%)  0 2/63 (3.17%)  2 0/62 (0.00%)  0 4/62 (6.45%)  6
Coagulation test abnormal * 1  9/62 (14.52%)  9 6/63 (9.52%)  6 13/62 (20.97%)  13 4/62 (6.45%)  4
Musculoskeletal and connective tissue disorders         
Back pain * 1  4/62 (6.45%)  4 8/63 (12.70%)  10 3/62 (4.84%)  3 4/62 (6.45%)  4
Nervous system disorders         
Dizziness * 1  1/62 (1.61%)  1 1/63 (1.59%)  1 5/62 (8.06%)  7 2/62 (3.23%)  2
Headache * 1  21/62 (33.87%)  48 28/63 (44.44%)  84 30/62 (48.39%)  63 23/62 (37.10%)  68
Reproductive system and breast disorders         
Dysmenorrhoea * 1  16/62 (25.81%)  30 18/63 (28.57%)  26 22/62 (35.48%)  47 26/62 (41.94%)  58
Metrorrhagia * 1  20/62 (32.26%)  34 18/63 (28.57%)  32 8/62 (12.90%)  12 4/62 (6.45%)  7
Breast discomfort * 1  0/62 (0.00%)  0 3/63 (4.76%)  3 4/62 (6.45%)  4 1/62 (1.61%)  1
Genital haemorrhage * 1  20/62 (32.26%)  32 19/63 (30.16%)  31 23/62 (37.10%)  33 8/62 (12.90%)  8
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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.
Sponsor will confirm the contents before disclosure.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Publications of Results:
Momoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese)
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00511797     History of Changes
Other Study ID Numbers: 91615
310283 ( Other Identifier: Company Internal )
First Submitted: August 3, 2007
First Posted: August 6, 2007
Results First Submitted: April 15, 2010
Results First Posted: October 4, 2010
Last Update Posted: January 26, 2017