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NCT04626596 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)
A Phase 3 study, sponsored by Organon and.
- Completed
- Registry status
- Phase 3
- Development phase
- 498
- Enrollment target
NCT04626596: Completed Phase 3 study, sponsored by Organon and.
NCT04626596 is a Phase 3 study that has completed, run by Organon and. The registered enrollment target is 498 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04626596, a Phase 3 study, has completed, sponsored by Organon and.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 498 participants
- Enrollment target
Study 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.
Primary Outcome
The Pearl Index is expressed as the number of on-treatment pregnancies per 100 woman-years of exposure. An on-treatment pregnancy is defined as a confirmed pregnancy with an estimated date of conception 36 months to 60 months since the date of implant insertion. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "at risk" cycles for conception will be included in this Pearl Index calc
Interventions
- COMBINATION_PRODUCT Radiopaque Etonogestrel (ENG) Implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 3 |
What the finished NCT04626596 record still lists
NCT04626596 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Radiopaque Etonogestrel (ENG) Implant is the first listed.
NCT04626596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04626596 about?
NCT04626596 is a clinical study titled "A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)". 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...
What is the current status of trial NCT04626596?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 498 participants. The study started on 2020-11-19. Estimated completion is 2024-12-30.
What interventions are being tested in trial NCT04626596?
The interventions under investigation include: Radiopaque Etonogestrel (ENG) Implant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04626596?
This trial is sponsored by Organon and, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04626596's enrollment target sits among peer trials
498 775th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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