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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

• 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

Locations
United States
Utah
Planned Parenthood Association of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Corinne Sexsmith, MPH
corinne.sexsmith@hsc.utah.edu
801-213-2419
Backup
Sarah Elliott, MPH
sarah.elliott@hsc.utah.edu
801-646-7066
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 790
Treatments
Active_comparator: Etonogestrel contraceptive implant with oral levonorgestrel
Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with either oral levonorgestrel 1.5mg
Placebo_comparator: Etonogestrel contraceptive implant with placebo
Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with placebo X 1 dose
Related Therapeutic Areas
Sponsors
Leads: Lori Gawron
Collaborators: Planned Parenthood Association of Utah

This content was sourced from clinicaltrials.gov