Status:
COMPLETED
Ovarian Function With ENG Implant and UPA Use
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
EARLY_PHASE1
Brief Summary
Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to people capable of pregnancy with recent unprotected intercourse ...
Detailed Description
Primary Objectives: 1. To determine point estimates for the incidence of ovulation within five days of oral ulipristal acetate (UPA) administration with same day etonogestrel (ENG) implant insertion ...
Eligibility Criteria
Inclusion
- Healthy females, age 18-35
- Fluent in English
- BMI \< 30 kg/m2
- No known contraindication to either the ENG contraceptive implant or Ulipristal Acetate (UPA) using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
- Not current pregnant and not at risk of pregnancy (defined as not having penile-vaginal intercourse or using a non-hormonal method of contraception such as a barrier method, condoms, diaphragm, or cervical cap, a copper IUD, or permanent contraception)
- Know the date of last menstrual period
- Have a regular menstrual cycle (24-35 days)
- Be willing to comply with all study requirements
- Be willing to avoid pregnancy for the duration of the study
Exclusion
- Currently pregnancy or breastfeeding
- Use of hormonal contraception or exogenous hormones (estrogen, progestogen, or HCG) in the last month (or past 6 months for depo medroxyprogesterone acetate) or planned use of such during the study
- Vaginal bleeding of unknown etiology
- Allergy to UPA or ENG
- Regular or planned use of glucocorticoids during the study
- Current or planned use of any medication that potentially interacts with UPA or ENG
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04291001
Start Date
September 4 2020
End Date
January 12 2024
Last Update
July 12 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132