Assessing Medical Menstrual Regulation in the United States

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

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

Study Overview

• Status: Recruiting
• Conditions: Menstrual Regulation
• Intervention / Treatment: Drug: Mifepristone; Drug: Misoprostol

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 Type: Interventional
• Enrollment (Anticipated): 284
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wendy R Sheldon, PhD; Phone Number: 212-448-1230; Email: wsheldon@gynuity.org

Study Locations

• United States
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Not yet recruiting
      • Carafem Health Center
      • Contact: Melissa Grant; Phone Number: 855-729-2272
      • Principal Investigator: Melissa Grant
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Recruiting
      • Carafem Health Center
      • Contact: Melissa Grant; Phone Number: 855-729-2272
      • Principal Investigator: Melissa Grant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Medical menstrual regulation; Mifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Wendy R Sheldon, PhD, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 8002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing de-identified data will be considered upon individual request.

Drug and device information, study documents

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