A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
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|ClinicalTrials.gov Identifier: NCT01277211|
Recruitment Status : Completed
First Posted : January 14, 2011
Results First Posted : September 15, 2014
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: ENG 120 µg + EE 15 µg intravaginal ring Drug: DRSP 3 mg + EE 30 µg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||983 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women|
|Actual Study Start Date :||September 19, 2011|
|Actual Primary Completion Date :||September 18, 2013|
|Actual Study Completion Date :||September 18, 2013|
Experimental: ENG-EE (NuvaRing)
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.
Drug: ENG 120 µg + EE 15 µg intravaginal ring
13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.
Other Name: NuvaRing
Active Comparator: DRSP-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.
Drug: DRSP 3 mg + EE 30 µg
13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.
Other Name: Yasmin
- Pearl Index, by Treatment Group [ Time Frame: Up to 1 year ]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).
- Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle [ Time Frame: Up to 1 year ]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.
- Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle [ Time Frame: Up to 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277211
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|