Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception

00152448

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.

2023-11-06

2028-01-31

2028-05-31

Recruiting

Early phase I

790

Inclusion Criteria: * Between 18-35 years old * Unprotected intercourse within 72 hours * Biologically capable of pregnancy (intact uterus without prior sterilization surgery * Fluent in English and/or Spanish * Have a regular menstrual cycle (21-35 days) * Known last menstrual period (+/- 3 days) * Working (cell) phone number * Willing to comply with the study requirements * Willing to abstain from any CYP3A4 inducer for 5 days Exclusion Criteria: * Current pregnancy (+urine pregnancy test in clinic) * Breastfeeding * Contraindication to ENG or LNG based on CDC MEC/SPR * Sterilization, hysterectomy, or has an IUD or contraceptive implant in place * Vaginal bleeding of unknown etiology * Previous use of EC in same cycle * Allergy to LNG or ENG * History of intolerance/ side effects with ENG Implant * Current (past 7 days) use of any CYP3A4 inducer * Plan to use any other steroid hormone in the next 4 weeks (testosterone, estrogen, progesterone) * Ended a pregnancy at or under 20 weeks gestational age within last 2 weeks * Ended a pregnancy over 20 weeks gestational age in last 6 weeks * Use of any injectable hormonal contraceptive (Depo-Provera) in the last 15 weeks * Use of any oral EC, contraceptive pills, patches, vaginal rings, or an IUD or Implant in the last 2 weeks

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial of the etonogestrel contraceptive implant randomized to same day oral levonorgestrel or placebo in emergency contraception patients', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The University of Utah Investigational Pharmacy encapsulated oral levonorgestrel and placebo pills and applied a randomization scheme that will not be broken until end of study or at the request of the data safety monitoring board', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 790, 'type': 'ESTIMATED'}}

2024-04-08