Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Phase 2

Not yet recruiting

• Conditions: Pregnancy Related; Pregnancy Early
• Interventions: Drug: Levonorgestrel; Drug: Mifepristone

• Registration Number: NCT06492889
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.

The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Study Start: 2024-07-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 286

Inclusion Criteria

• Age 15-49 years
• General good health
• Does not want to be pregnant
• History of regular monthly menstrual cycles (+/- 3 days)
• Missed menses of 2 to 8 days
• Sexual activity in the past month
• Willing and able to sign consent forms
• Willing to return for a follow-up visit
• Willing to provide urine sample at enrollment and follow-up

Exclusion Criteria

• Known allergies or contraindications to either study drug
• Symptoms or risk factors for ectopic pregnancy
• Current use of an IUD, contraceptive implant or injectable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel plus mifepristone	Mifepristone	Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.
Levonorgestrel plus mifepristone	Levonorgestrel	Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.
Placebo plus mifepristone	Mifepristone	Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.

Primary Outcome Measures

Name	Time	Method
Effectiveness of the missed period pills regimen	Two weeks	Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment
Efficacy of the missed period pills regimen	Two weeks	Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment

Secondary Outcome Measures

Name	Time	Method
Effectiveness at inducing return of menses within 10 days of missed menses	One to two weeks	Proportion of participants who experience menstrual bleeding after taking the study medications
Safety/side effects	Two weeks	Incidence of side effects and complications
Acceptability	Two weeks	Proportion of participants who report that the missed period pills service was acceptable or highly acceptable