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Assessing Medical Menstrual Regulation in the United States

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ClinicalTrials.gov Identifier: NCT03972358
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of participants who report that MMR was acceptable or highly acceptable during the exit interview [ Time Frame: Up to 28 days after mifepristone administration ]
    Acceptability of MMR


Secondary Outcome Measures :
  1. Number of participants not pregnant at follow-up [ Time Frame: Up to 28 days after mifepristone administration ]
    Efficacy

  2. Number of participants with adverse events and/or side effects [ Time Frame: 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 [ Time Frame: Up to 28 days after mifepristone administration ]
    Experiences, perceived advantages and disadvantages


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972358


Contacts
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Contact: Wendy R Sheldon, PhD 212-448-1230 wsheldon@gynuity.org

Locations
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United States, Illinois
Carafem Health Center Not yet recruiting
Skokie, Illinois, United States, 60076
Contact: Melissa Grant    855-729-2272      
Principal Investigator: Melissa Grant         
United States, Maryland
Carafem Health Center Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Melissa Grant    855-729-2272      
Principal Investigator: Melissa Grant         
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Wendy R Sheldon, PhD Gynuity Health Projects
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03972358    
Other Study ID Numbers: 8002
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing de-identified data will be considered upon individual request.

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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:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
 Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents