Same Day Oral EC and Implant Initiation

Contraception Clinical Trial

Official title:

A Prospective Observational Study of Preference for and Efficacy of Oral Levonorgestrel Emergency Contraception With Same Day Etonogestrel Contraceptive Implant Compared to Established Pregnancy Rates With Oral Levonorgestrel Emergency Contraception Alone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04678817
• Other study ID #: 137011
• Status: Active, not recruiting
• Start date: January 15, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 hormonal IUD or oral EC. Current guidelines allow for same-day implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. This study will look at pregnancy rates and clients willingness to receive same-day implant + oral EC and same-day IUDs.

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 allow women presenting for EC to be offered the LNG IUD. These recommendations leave out the only other long-acting reversible contraceptive (LARC), the ENG implant. Current guidelines allow for same-day ENG implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. We lack data on pregnancy risk for the EC-eligible population desiring same-day ENG implant placement and oral EC.

Women presenting for EC often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. Interest in LARC use continues to increase as well as same-day contraception initiation at the time of an EC encounter. Women presenting for EC may not have considered LARC options before. Generating estimates and continuation rates for same-day initiation with an EC encounter will improve contraceptive options for women seeking EC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 297
• Est. completion date: January 1, 2025
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Contraception
• Emergencies

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah	Salt Lake City	Utah
United States	Planned Parenthood Association of Utah	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate at one-month	To determine a point estimate for the one-month pregnancy rate following guideline supported same-day initiation of an etonogestrel (ENG) implant plus oral levonorgestrel (LNG) emergency contraception (EC).	one month
Primary	Comparing Proportions of EC clients desiring ENG implant with oral EC vs IUD	To determine the proportion of EC clients willing to initiate a same-day ENG implant with oral LNG EC compared to same-day initiation of intrauterine devices for EC.	2 years
Secondary	Continuation Rates	6- and 12-month continuation rates of the ENG implant with same-day initiation at an EC encounter.	6 and 12 months
Secondary	Discontinuation Timing and Reasons	Timing and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.	12 months