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Ovarian Function With ENG Implant and UPA Use

NCT04291001 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-12

Study results available
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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 to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at least 1 week following UPA, as well as waiting 7 days before relying on the implant for contraception after initiation alone. This pilot will assess the effects of the implant alone and the implant inserted with same-day as UPA usage on ovarian activity. A total of 40 people capable of pregnancy desiring the implant, who are not at risk for pregnancy during the study timeline, will be recruited. Participants will be randomized to implant alone or same-day implant + oral UPA. Participants will have daily ultrasounds and blood draws to assess timing of ovulation for 1 week and then an exit visit at 14 days after randomization. The primary outcome is the incidence of ovulation in the 2 randomized treatment groups. Participants may continue the implant after the study per FDA guidelines and rely on it for contraception after the study is completed.

Conditions

  • Contraception

Interventions

DEVICE

ENG implant

This is an FDA-approved contraceptive device

DRUG

oral ulipristal acetate

This is an FDA-approved oral emergency contraceptive

Sponsors & Collaborators

Principal Investigators

  • Lori Gawron, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2022-10-10
Completion
2024-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291001 on ClinicalTrials.gov