Assessing Medical Menstrual Regulation in the United States

NCT03972358 | Unknown Phase 2 FDA Drug

• 1 other identifier: 8002
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Menstrual Regulation

Outcome Measures

Primary Outcomes (1)

• Number of participants who report that MMR was acceptable or highly acceptable during the exit interview

  Acceptability of MMR

  Up to 28 days after mifepristone administration

Secondary Outcomes (3)

• Number of participants not pregnant at follow-up

  Up to 28 days after mifepristone administration

• Number of participants with adverse events and/or side effects

  Up to 28 days after mifepristone administration

• Perceived advantages and disadvantages of MMR as reported by participants during the exit interview

  Up to 28 days after mifepristone administration

Study Arms (1)

Medical menstrual regulation

EXPERIMENTAL

Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).

Drug: Mifepristone; Drug: Misoprostol

Interventions

Mifepristone DRUG

All participants will receive 200 mg mifepristone, to be taken orally on day 1.

Medical menstrual regulation

Misoprostol DRUG

All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)

Medical menstrual regulation

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (2)

Carafem Health Center

Skokie, Illinois, 60076, United States

NOT YET RECRUITING

Carafem Health Center

Chevy Chase, Maryland, 20815, United States

RECRUITING

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Wendy R Sheldon, PhD

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy R Sheldon, PhD

CONTACT

212-448-1230; wsheldon@gynuity.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: February 12, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)