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Trial record 50 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01277211
Recruitment Status : Completed
First Posted : January 14, 2011
Results First Posted : September 15, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: ENG 120 µg + EE 15 µg intravaginal ring
Drug: DRSP 3 mg + EE 30 µg
Enrollment 983
Recruitment Details  
Pre-assignment Details Of the 983 participants randomized, 946 received treatment and 37 discontinued prior to receiving treatment.
Arm/Group Title ENG-EE (NuvaRing) DRSP-EE
Hide Arm/Group Description Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE. Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Period Title: Overall Study
Started 738 245
Treated 714 232
Completed 588 182
Not Completed 150 63
Reason Not Completed
Adverse Event             60             22
Pregnancy             9             4
Lost to Follow-up             14             9
Did not wish to continue             17             0
Withdrew Consent             9             9
Non-compliance with protocol             13             4
Did not meet protocol eligibility             1             0
Administrative             3             0
Pregnancy wish             0             2
Discontinued prior to treatment             24             13
Arm/Group Title ENG-EE (NuvaRing) DRSP-EE Total
Hide Arm/Group Description Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE. Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE. Total of all reporting groups
Overall Number of Baseline Participants 714 232 946
Hide Baseline Analysis Population Description
All Subjects Treated (AST) group, which consisted of all randomized participants who used at least one ring/pill.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 714 participants 232 participants 946 participants
31.8  (4.0) 31.2  (3.9) 31.7  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 714 participants 232 participants 946 participants
Female
714
 100.0%
232
 100.0%
946
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pearl Index, by Treatment Group
Hide Description Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).
Arm/Group Title ENG-EE (NuvaRing) DRSP-EE
Hide Arm/Group Description:
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Overall Number of Participants Analyzed 662 216
Mean (95% Confidence Interval)
Unit of Measure: Pregnancies per 100 woman-years
1.92
(0.92 to 3.53)
3.12
(1.01 to 7.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments [Not Specified]
Method Poisson distribution method
Comments Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.
Method of Estimation Estimation Parameter Ratio of Pearl Indices
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.19 to 2.29
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Hide Description Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Group, which consisted of all randomized participants who used at least one ring/pill.
Arm/Group Title ENG-EE (NuvaRing) DRSP-EE
Hide Arm/Group Description:
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Overall Number of Participants Analyzed 714 232
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 (n=598,199) 18.6 21.6
Cycle 2 (n=604,195) 12.3 18.5
Cycle 3 (n=578,196) 8.5 14.3
Cycle 4 (n=587,194) 7.5 15.5
Cycle 5 (n=592,187) 6.8 8.0
Cycle 6 (n=590,185) 6.9 10.8
Cycle 7 (n=583,186) 7.5 11.3
Cycle 8 (n=585,188) 6.3 10.6
Cycle 9 (n=576,187) 6.9 8.0
Cycle 10 (n=572,183) 5.9 10.4
Cycle 11 (n=578,177) 4.2 7.9
Cycle 12 (n=569,176) 5.3 9.7
Cycle 13 (n=544,173) 6.4 11.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 1
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-9.9 to 3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 2
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-12.7 to -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 3
Estimated Value -5.8
Confidence Interval (2-Sided) 95%
-11.8 to -0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 4
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-14.0 to -2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 5
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.4 to 2.6
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 6
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-9.5 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 7
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-9.4 to 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 8
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-9.8 to -0.0
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 9
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-6.2 to 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 10
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-10.0 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 11
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-8.9 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 12
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-9.9 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 13
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-10.4 to -0.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Hide Description Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Group, which consisted of all randomized participants who used at least one ring/pill.
Arm/Group Title ENG-EE (NuvaRing) DRSP-EE
Hide Arm/Group Description:
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Overall Number of Participants Analyzed 714 232
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 (n=596,199) 8.6 14.6
Cycle 2 (n=602,195) 4.8 9.7
Cycle 3 (n=577,196) 5.2 11.7
Cycle 4 (n=586,194) 4.1 7.7
Cycle 5 (n=590,187) 5.4 6.4
Cycle 6 (n=588,185) 5.8 9.7
Cycle 7 (n=581,186) 3.4 7.5
Cycle 8 (n=583,188) 5.0 6.9
Cycle 9 (n=575,187) 4.3 8.6
Cycle 10 (n=571,183) 3.7 6.6
Cycle 11 (n=576,177) 3.0 7.3
Cycle 12 (n=568,176) 4.0 10.2
Cycle 13 (n=543,173) 5.9 10.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 1
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-12.0 to -1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 2
Estimated Value -4.9
Confidence Interval (2-Sided) 95%
-10.1 to -1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 3
Estimated Value -6.5
Confidence Interval (2-Sided) 95%
-12.0 to -2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 4
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-8.5 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.609
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 5
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-5.7 to 2.5
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 6
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-9.3 to 0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 7
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-9.0 to -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 8
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-6.7 to 1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 9
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-9.3 to -0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 10
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-7.6 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 11
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-9.4 to -1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 12
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-11.7 to -2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ENG-EE (NuvaRing), DRSP-EE
Comments For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages, Cycle 13
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-10.2 to -0.1
Estimation Comments [Not Specified]
Time Frame Up to 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ENG-EE (NuvaRing) DRSP-EE
Hide Arm/Group Description Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE. Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
All-Cause Mortality
ENG-EE (NuvaRing) DRSP-EE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ENG-EE (NuvaRing) DRSP-EE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/714 (0.28%)      4/232 (1.72%)    
Infections and infestations     
Sinusitis  1  1/714 (0.14%)  1 0/232 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intraductal proliferative breast lesion  1  1/714 (0.14%)  1 0/232 (0.00%)  0
Invasive ductal breast carcinoma  1  0/714 (0.00%)  0 1/232 (0.43%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/714 (0.00%)  0 2/232 (0.86%)  2
Vascular disorders     
Deep vein thrombosis  1  0/714 (0.00%)  0 1/232 (0.43%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ENG-EE (NuvaRing) DRSP-EE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/714 (0.00%)      0/232 (0.00%)    
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.
The sponsor must have the opportunity to review and comment on data analysis and presentation for all abstracts, manuscripts, and slide presentations that report any results of this trial 45 days prior to the submission for publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharpe & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01277211     History of Changes
Other Study ID Numbers: P06450
First Submitted: January 12, 2011
First Posted: January 14, 2011
Results First Submitted: September 8, 2014
Results First Posted: September 15, 2014
Last Update Posted: August 31, 2018