Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Pregnancy Early
• Intervention / Treatment: Drug: Levonorgestrel; Drug: Mifepristone

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Manuel Bousieguez; Phone Number: 212-448-1230; Email: mbousieguez@gynuity.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levonorgestrel plus mifepristone; Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.	Drug: Levonorgestrel; Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel; Drug: Mifepristone; Participants in both groups will receive one tablet of 200 mg mifepristone
Experimental: Placebo plus mifepristone; Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.	Drug: Mifepristone; Participants in both groups will receive one tablet of 200 mg mifepristone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Cuidado Integral de la Mujer, Gineclinic, S.C.; Servicios de Salud Medieg, A. C
• Investigators: Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Estimated): July 22, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Levonorgestrel; Mifepristone
• Other Study ID Numbers: 8007 (Rare Disease Clinical Research Network)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No