NCT03972358

Assessing Medical Menstrual Regulation in the United States

Assessing Acceptability and Use of Medical Menstrual Regulation in the United States

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Conditions

• Menstrual Regulation

Interventions

Type	Name	Description
DRUG	Mifepristone	All participants will receive 200 mg mifepristone, to be taken orally on day 1.
DRUG	Misoprostol	All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)

Timeline

• Start date: 2020-02-12
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-06-03
• Last updated: 2021-03-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study