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A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)

NCT04626596 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

  • Contraception

Interventions

COMBINATION_PRODUCT

Radiopaque Etonogestrel (ENG) Implant

68 mg subdermal implant

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Clinical Lead · Organon and Co

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626596 on ClinicalTrials.gov