Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Lori Gawron
Study ID
NCT06162611
Phase
PHASE4
Status
Recruiting
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Conditions

  • Emergency Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg — DRUG
    Single pill of oral levonorgestrel 1.5mg X 1 dose (e.g. Plan B) same day as contraceptive implant insertion
  • Etonogestrel implant with oral placebo — DEVICE
    Single pill of placebo same day as contraceptive implant insertion

Study Details

Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. This proposal will identify the most effective way to start an implant for emergency contraception using a randomized controlled trial comparing pregnancy risk between those receiving the implant vs. the implant plus oral emergency contraception (EC). Data from this project will inform clinical practice and add another option, the implant, for those desiring a long acting, highly effective contraceptive method when they present for emergency contraception.

Key Dates

Start date
Nov 6, 2023
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
May 31, 2028

Study Design

Enrollment
790 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Etonogestrel contraceptive implant with oral levonorgestrel
    Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with either oral levonorgestrel 1.5mg
  • Placebo Comparator: Etonogestrel contraceptive implant with placebo
    Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with placebo X 1 dose

Primary Outcome Measure

Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception [ Time Frame: 1 month after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Planned Parenthood Association of UtahSalt Lake CityUtah84102
Corinne Sexsmith
David Turok, MD, MPH (SUB_INVESTIGATOR)

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By research site
Planned Parenthood Association of Utah· Salt Lake City, UT