Emergency Contraception Clinical Trial
Official title:
Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception
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.
Status | Recruiting |
Enrollment | 790 |
Est. completion date | May 31, 2028 |
Est. primary completion date | January 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Planned Parenthood Association of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Lori Gawron | Planned Parenthood Association of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception | Pregnancy rate = number of pregnancies / participants in the placebo arm | 1 month after enrollment | |
Primary | Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category | Pregnancy rate = # of pregnancies / participants in the placebo arm stratified by BMI category | 1 month after enrollment | |
Primary | Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception | Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm | 1 month after enrollment | |
Primary | Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category | Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm stratified by BMI category | 1 month after enrollment | |
Primary | Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm | Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone | 5 days after implant insertion | |
Primary | Ovulation frequency within 5 days of implant insertion in the placebo arm | Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone | 5 days after implant insertion | |
Secondary | Implant continuation | Participants continuing implant use at one month as a proportion of all participants having successful placement of implant at study entry. Measured by probabilities estimated using Kaplan-Meier approach. | 4 weeks after insertion | |
Secondary | Implant satisfaction | Likelihood of satisfaction by study group using ordinal regression. Measured by 5-point ordinal scale (5-point ordinal scale: (1) very unsatisfied, (2) unsatisfied, (3) neutral, (4) satisfied, (5) very satisfied). Measured by | 4 weeks after insertion |
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