Trials / Terminated
TerminatedNCT02524288
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring in Women at Risk for Pregnancy (MK-8342B-061)
A Phase 3, Single Arm, Clinical Trial to Study the Contraceptive Efficacy and Safety of the MK-8342B (Etonogestrel + 17β-Estradiol) Vaginal Ring in Healthy Women 18 Years of Age and Older, At Risk for Pregnancy
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,941 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of the ENG-E2 vaginal ring.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ENG-E2 125 μg/300 μg vaginal ring | Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
Timeline
- Start date
- 2015-08-31
- Primary completion
- 2016-09-16
- Completion
- 2016-09-16
- First posted
- 2015-08-14
- Last updated
- 2024-05-17
- Results posted
- 2017-09-25
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02524288. Inclusion in this directory is not an endorsement.