Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication FOR VAGINAL USE ONLY NuvaRing ® is indicated for use by females of reproductive age to prevent pregnancy. NuvaRing is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. ( 1 ) FDA label
Also known as NuvaRing
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 an investigational contraceptive developed for pregnancy prevention in women. It is a small molecule combination product containing etonogestrel and ethinyl estradiol, delivered vaginally. It has been studied in a Phase 3 trial in Chinese women aged 18 years and older who were healthy volunteers.
Organon & Co. (ticker OGN) is the developer of ENG 120 µg + EE 15 µg intravaginal ring. The company sponsored the Phase 3 contraception study of the vaginal ring in Chinese women.
ENG 120 µg + EE 15 µg intravaginal ring is in Phase 3 development for contraception. Its Phase 3 trial has been completed, and the program remains investigational rather than approved.
ENG 120 µg + EE 15 µg intravaginal ring was evaluated in the Phase 3 trial NCT01277211, titled A Study to Evaluate the Effectiveness of NuvaRing to Prevent Pregnancies in Chinese Women (P06450). The completed study enrolled 983 female participants aged 18 years and older and used an active-controlled design.
The Phase 3 trial of ENG 120 µg + EE 15 µg intravaginal ring, NCT01277211, enrolled 983 participants. It was a randomized, active-controlled study conducted in healthy female volunteers aged 18 years and older, and it has been completed.