RECRUITING

Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-06
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06162611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18-35 years old
  2. * Unprotected intercourse within 72 hours
  3. * Biologically capable of pregnancy (intact uterus without prior sterilization surgery
  4. * Fluent in English and/or Spanish
  5. * Have a regular menstrual cycle (21-35 days)
  6. * Known last menstrual period (+/- 3 days)
  7. * Working (cell) phone number
  8. * Willing to comply with the study requirements
  9. * Willing to abstain from any CYP3A4 inducer for 5 days
  1. * Current pregnancy (+urine pregnancy test in clinic)
  2. * Breastfeeding
  3. * Contraindication to ENG or LNG based on CDC MEC/SPR
  4. * Sterilization, hysterectomy, or has an IUD or contraceptive implant in place
  5. * Vaginal bleeding of unknown etiology
  6. * Previous use of EC in same cycle
  7. * Allergy to LNG or ENG
  8. * History of intolerance/ side effects with ENG Implant
  9. * Current (past 7 days) use of any CYP3A4 inducer
  10. * Plan to use any other steroid hormone in the next 4 weeks (testosterone, estrogen, progesterone)
  11. * Ended a pregnancy at or under 20 weeks gestational age within last 2 weeks
  12. * Ended a pregnancy over 20 weeks gestational age in last 6 weeks
  13. * Use of any injectable hormonal contraceptive (Depo-Provera) in the last 15 weeks
  14. * Use of any oral EC, contraceptive pills, patches, vaginal rings, or an IUD or Implant in the last 2 weeks

Contacts and Locations

Study Contact

Corinne Sexsmith, MPH
CONTACT
801-213-2419
corinne.sexsmith@hsc.utah.edu
Sarah Elliott, MPH
CONTACT
801-646-7066
sarah.elliott@hsc.utah.edu

Principal Investigator

Lori Gawron, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
United States

Collaborators and Investigators

Sponsor: Lori Gawron

  • Lori Gawron, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-06
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2023-11-06
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • contraception
  • etonogestrel implant
  • oral levonorgestrel

Additional Relevant MeSH Terms

  • Emergency Contraception