Assessing Medical Menstrual Regulation in the United States

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

Sponsors

Lead Sponsor: Gynuity Health Projects

Source 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

Overall Status Recruiting
Start Date 2020-02-12
Completion Date 2021-12-31
Primary Completion Date 2021-12-31
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants who report that MMR was acceptable or highly acceptable during the exit interview Up to 28 days after mifepristone administration
Secondary Outcome
Measure Time Frame
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
Enrollment 284
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mifepristone

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

Arm Group Label: Medical menstrual regulation

Intervention Type: Drug

Intervention Name: Misoprostol

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

Arm Group Label: Medical menstrual regulation

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

49 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Wendy R Sheldon, PhD Principal Investigator Gynuity Health Projects
Overall Contact

Last Name: Wendy R Sheldon, PhD

Phone: 212-448-1230

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Carafem Health Center | Skokie, Illinois, 60076, United States Not yet recruiting Melissa Grant 855-729-2272 Melissa Grant Principal Investigator
Carafem Health Center | Chevy Chase, Maryland, 20815, United States Recruiting Melissa Grant 855-729-2272 Melissa Grant Principal Investigator
Location Countries

United States

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Medical menstrual regulation

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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