Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01277211 | A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450) | PHASE3 | COMPLETED | 983 | — | — | Sep 19, 2011 | Sep 18, 2013 | Jun 20, 2024 | - | — |
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).
| Arm | Type | Description |
|---|---|---|
| ENG-EE (NuvaRing) | EXPERIMENTAL | 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. |
| DRSP-EE | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| ENG 120 µg + EE 15 µg intravaginal ring | DRUG | 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. |
| DRSP 3 mg + EE 30 µg | DRUG | 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. |
Key Inclusion Criteria: * Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use * Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles * Body mass index ≥18 and ≤29 kg/m\^2 Key Exclusion Criteria...