Assessing Medical Menstrual Regulation in the United States

Phase 2

• Conditions: Menstrual Regulation
• Interventions: Drug: Mifepristone; Drug: Misoprostol

• Registration Number: NCT03972358
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This study will assess the acceptability and use of medical menstrual regulation among women in the United States.

Detailed Description

Medical menstrual regulation (MMR) entails the use of uterine evacuation medications by women with late menses without confirming pregnancy status. Provision of MMR in the United States could expand reproductive choice and service options for women. This study will collect data on the acceptability, efficacy, safety and feasibility of MMR among women with missed menses of 1-21 days

Study Timeline

• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2020-02-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 284

Inclusion Criteria

1. Age 18-49 years
2. General good health
3. Does not want to be pregnant
4. Does not want to verify pregnancy status at the study site
5. History of regular monthly menstrual cycles
6. Missed menses of 1-21 days
7. Sexual activity in the past 2 months
8. Willing and able to sign consent forms
9. Willing to provide urine sample at enrollment
10. Willing to return for a follow-up visit

Exclusion Criteria

1. Known allergies or contraindications to mifepristone and/or misoprostol
2. Symptoms of or risk factors for ectopic pregnancy
3. Current use of an IUD, contraceptive implant or injectable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medical menstrual regulation	Mifepristone	Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).
Medical menstrual regulation	Misoprostol	Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).

Primary Outcome Measures

Name	Time	Method
Number of participants who report that MMR was acceptable or highly acceptable during the exit interview	Up to 28 days after mifepristone administration	Acceptability of MMR

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events and/or side effects	Up to 28 days after mifepristone administration	Safety and side effects
Number of participants not pregnant at follow-up	Up to 28 days after mifepristone administration	Efficacy
Perceived advantages and disadvantages of MMR as reported by participants during the exit interview	Up to 28 days after mifepristone administration	Experiences, perceived advantages and disadvantages

Trial Locations

Locations (1)

Carafem Health Center; 🇺🇸 Chevy Chase, Maryland, United States