ENG Implant for Birth Control

Recruiting in Palo Alto (17 mi)

+149 other locations

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Lead

Principal Investigator

Organon and Co

Eligibility Criteria

This trial is for women in good health, not going through menopause, who have had regular menstrual cycles and a palpable ENG implant for 3 years. They must be sexually active with a fertile male partner and want contraception without using other methods. Participants should commit to the study's procedures and timeline.

Inclusion Criteria

I do not plan to become pregnant for the next 2 years and agree to use only the study's birth control method.

I do not plan to become pregnant for the next 2 years and will not use other birth control methods.

History of regular menstrual cycles of 21 to 35 days before the insertion of the ENG implant or before hormonal contraceptive use (which may have preceded the current implant use)

Exclusion Criteria

History of subfertility or infertility

Presence of more than one ENG implant

I've had unexplained and frequent vaginal bleeding in the last year.

Treatment Details

Interventions

• Etonogestrel (ENG) Implant (Progestin-only Contraceptive)

Trial Overview The study tests if the Etonogestrel (ENG) contraceptive implant remains effective in preventing pregnancy during the fourth and fifth years of use. It currently has approval for three years, but this trial seeks to confirm its safety and efficacy beyond that period.

Participant Groups

Group I: ENG implant Experimental Treatment 1 Intervention

Participants will have the ENG 68 mg implant inserted and in place for 36 months before enrollment. The ENG implant will remain in place for an additional 24 months.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley