Assessing Medical Menstrual Regulation in the United States
NCT ID: NCT03972358
Last Updated: 2021-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
284 participants
INTERVENTIONAL
2020-02-12
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
NCT00994734
Mifepristone and Mid-Trimester Termination of Pregnancy
NCT00382538
Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
NCT01811056
Study of Immediate Start of Progestin Contraceptives in Medical Abortion
NCT01902485
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
NCT01798017
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Medical menstrual regulation
Mifepristone 200 mg orally on day 1.
Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).
Mifepristone
All participants will receive 200 mg mifepristone, to be taken orally on day 1.
Misoprostol
All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mifepristone
All participants will receive 200 mg mifepristone, to be taken orally on day 1.
Misoprostol
All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Symptoms of or risk factors for ectopic pregnancy
3. Current use of an IUD, contraceptive implant or injectable
18 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gynuity Health Projects
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wendy R Sheldon, PhD
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Carafem Health Center
Skokie, Illinois, United States
Carafem Health Center
Chevy Chase, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Melissa Grant
Role: primary
Melissa Grant
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
8002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.