Trials / Completed
CompletedNCT04626596
A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)
A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 498 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- 35 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Radiopaque Etonogestrel (ENG) Implant | 68 mg subdermal implant |
Timeline
- Start date
- 2020-11-19
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
- First posted
- 2020-11-12
- Last updated
- 2026-02-18
Locations
67 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04626596. Inclusion in this directory is not an endorsement.