Assessing Medical Menstrual Regulation in the United States

• Sponsor: Gynuity Health Projects (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03972358
• Collaborator: (none)
• Enrollment: 284
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 22.6
• Patients Per Site: 142
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Menstrual Regulation	Drug: Mifepristone; Drug: Misoprostol	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 284 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessing Acceptability and Use of Medical Menstrual Regulation in the United States
• Actual Study Start Date: Feb 12, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of participants not pregnant at follow-up [Up to 28 days after mifepristone administration]

   Efficacy

2. Number of participants with adverse events and/or side effects [Up to 28 days after mifepristone administration]

   Safety and side effects

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carafem Health Center	Skokie	Illinois	United States	60076
2	Carafem Health Center	Chevy Chase	Maryland	United States	20815

Sponsors and Collaborators

• Gynuity Health Projects

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynuity Health Projects
• ClinicalTrials.gov Identifier: NCT03972358
• Other Study ID Numbers: 8002
• First Posted: Jun 3, 2019
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Misoprostol; Mifepristone

Study Results

No Results Posted as of Mar 24, 2021