Status:
COMPLETED
Same Day Oral EC and Implant Initiation
Lead Sponsor:
University of Utah
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Brief Summary
This is a study for clients presenting for emergency contraception (EC). EC is used to prevent pregnancy after unprotected intercourse. Clients presenting for EC may be offered either the copper or ho...
Detailed Description
Recommended options for EC include oral EC (levonorgestrel (LNG), ulipristal acetate (UPA), or combination oral contraceptive pills), or the copper intrauterine device (IUD). Recent data will also all...
Eligibility Criteria
Inclusion
- Healthy women
- Age 18-35 years
- Fluent in English and/or Spanish
- BMI \< 30 kg/m2
- No known contraindication to either the ENG contraceptive implant or oral LNG EC using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
- Negative urine pregnancy test
- Willing to abstain from further UPI in the 7 days following insertion
- Know the date of their last menstrual period
- Regular menstrual cycle (24-35 days)
- Be willing to comply with the study requirements
- Desiring to avoid pregnancy for at least 12 months
Exclusion
- Current pregnancy or breastfeeding
- Previous use of oral EC in the current cycle
- Report of UPI beyond 5 days in current cycle
- Vaginal bleeding of unknown etiology
- Allergy to LNG or ENG, IUD or implant in-place
- History of permanent contraception through sterilization or hysterectomy
- Monogamous partner with a vasectomy
- Depo-provera injection within past 15 weeks
Key Trial Info
Start Date :
February 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04678817
Start Date
February 17 2021
End Date
March 15 2024
Last Update
April 15 2025
Active Locations (2)
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1
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102
2
Planned Parenthood Association of Utah
West Valley City, Utah, United States, 84119