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ENG 120 µg+ EE 15 µg intravaginal ring · 1 trial · 1 indication
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...
ENG 120 µg+ EE 15 µg intravaginal ring is used for contraception. It is a combined hormonal contraceptive ring designed to prevent pregnancy. The drug is currently in Phase 3 clinical development and is being studied in a completed trial that evaluated its effectiveness in preventing pregnancies in Chinese women.
ENG 120 µg+ EE 15 µg intravaginal ring is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the contraceptive ring's effectiveness and safety.
ENG 120 µg+ EE 15 µg intravaginal ring is in Phase 3 clinical development. The Phase 3 trial, identified as NCT01277211, has been completed. The drug is investigational and has not been approved by regulatory authorities. It is being studied for use as a contraceptive method.
ENG 120 µg+ EE 15 µg intravaginal ring has one completed Phase 3 clinical trial, NCT01277211, titled 'A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)'. This randomized, active-controlled trial enrolled 983 female participants aged 18 years and older.
ENG 120 µg+ EE 15 µg intravaginal ring is being studied in a clinical trial that references NuvaRing in its title. The trial evaluates the effectiveness of NuvaRing to prevent pregnancies in Chinese women. The drug is a combined hormonal contraceptive ring containing etonogestrel and ethinyl estradiol.