Menstrual RegulationPhase 2NCT03972358
Assessing Medical Menstrual Regulation in the United States
A Phase 2 study testing Mifepristone and Misoprostol in people with Menstrual Regulation, run by Gynuity Health Projects at 2 sites in United States.
Trial summary
This study will assess the acceptability and use of medical menstrual regulation among women in the United States. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Regulation
- What is being tested?
- Mifepristone and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-49 years
- General good health
- Does not want to be pregnant
- Does not want to verify pregnancy status at the study site
- History of regular monthly menstrual cycles
- Missed menses of 1-21 days
Show all 10Show fewer
- Sexual activity in the past 2 months
- Willing and able to sign consent forms
- Willing to provide urine sample at enrollment
- Willing to return for a follow-up visit
Who cannot join
- Known allergies or contraindications to mifepristone and/or misoprostol
- Symptoms of or risk factors for ectopic pregnancy
- Current use of an IUD, contraceptive implant or injectable
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Carafem Health Center
Chevy Chase, Maryland, 20815
Melissa Grant, 855-729-2272
Melissa Grant
- Not yet recruiting
Carafem Health Center
Skokie, Illinois, 60076
Melissa Grant, 855-729-2272
Melissa Grant
About this study
Official title: 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.
Read the 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
- Conditions
- Menstrual Regulation
- Being tested
- Mifepristone, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
All participants will receive 200 mg mifepristone, to be taken orally on day 1.
MisoprostolDrug
All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)
| Study group | Role | What they receive |
|---|---|---|
| Medical menstrual regulation | Experimental | Mifepristone 200 mg orally on day 1.
Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone). Receives: Drug: Mifepristone; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who report that MMR was acceptable or highly acceptable during the exit interview
Acceptability of MMR
Measured: Up to 28 days after mifepristone administration
Secondary outcomes (3)
Number of participants not pregnant at follow-up
Efficacy
Measured: Up to 28 days after mifepristone administration
Number of participants with adverse events and/or side effects
Safety and side effects
Measured: 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
Measured: Up to 28 days after mifepristone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start12 Feb 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy R Sheldon, PhD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972358
- Sponsor's protocol ID
- 8002
- Status last verified
- Mar 2021
- First submitted
- 28 May 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing de-identified data will be considered upon individual request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Acceptability and Use of Medical Menstrual Regulation in the United States
- ClinicalTrials.gov ID
- NCT03972358
- Acronym / sponsor ID
- 8002
- Conditions
- Menstrual Regulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical menstrual regulation | Experimental | Drug: Mifepristone, Drug: MisoprostolMifepristone 200 mg orally on day 1. Misoprostol 800 mcg buccally on day 2 (24 hours after mifepristone). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18-49 years
- General good health
- Does not want to be pregnant
- Does not want to verify pregnancy status at the study site
- History of regular monthly menstrual cycles
Key exclusion criteria (3 listed)
- Known allergies or contraindications to mifepristone and/or misoprostol
- Symptoms of or risk factors for ectopic pregnancy
- Current use of an IUD, contraceptive implant or injectable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneAll participants will receive 200 mg mifepristone, to be taken orally on day 1. | Drug | Medical menstrual regulation |
| MisoprostolAll participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2) | Drug | Medical menstrual regulation |
Primary outcome
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
3 secondary outcomes
Number of participants not pregnant at follow-up
Time frame: Up to 28 days after mifepristone administration
Number of participants with adverse events and/or side effects
Time frame: Up to 28 days after mifepristone administration
Perceived advantages and disadvantages of MMR as reported by participants during the exit interview
Time frame: Up to 28 days after mifepristone administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No. Sharing de-identified data will be considered upon individual request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy R Sheldon, PhD principal investigator
Gynuity Health Projects
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone and Misoprostol in people with Menstrual Regulation, run by Gynuity Health Projects at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy R Sheldon, PhD (212-448-1230, wsheldon@gynuity.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.