Status:
RECRUITING
Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
Lead Sponsor:
Lori Gawron
Collaborating Sponsors:
Planned Parenthood Association of Utah
Conditions:
Emergency Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Oral emergency contraception (EC), is commonly used after recent unprotected intercourse to avoid undesired pregnancy, but does not provide ongoing contraception. Rigorous data allow for use of intrau...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT06162611
Start Date
November 6 2023
End Date
May 31 2028
Last Update
April 24 2025
Active Locations (1)
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1
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102