- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07671989
Period Pills for Menstrual Regulation: A New Reproductive Health Option (Period Pills)
Study Overview
Status
Intervention / Treatment
Detailed Description
Period pills (a combination of mifepristone and misoprostol) for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. In the United States (U.S.), a handful of providers currently offer period pills alongside other contraceptive and abortion services in their practice (https://www.periodpills.org/providers). This proposed study would aim to assess the acceptability of this growing service as a fertility regulation method to be utilized before a person confirms they are pregnant.
Dr. Ushma Upadhyay (Professor) and Dr. Tania Serna (Associate Clinical Professor) at UCSF's Department of Obstetrics, Gynecology & Reproductive Science are proposing the Period Pills Study to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is late, or missed. This study will aim to recruit 100 participants who have a late period to address research questions that focus on the feasibility and acceptability of using period pills for menstrual regulation.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jennifer Ko, MLIS
- Phone Number: 415-353-9113
- Email: jennifer.ko@ucsf.edu
Study Contact Backup
- Name: Ushma D Upadhyay, PhD, MPH
- Phone Number: 415-353-4626
- Email: ushma.upadhyay@ucsf.edu
Study Locations
-
-
California
-
Oakland, California, United States, 94612
- Active, not recruiting
- UCSF Advancing New Standards in Reproductive Health (ANSIRH)
-
-
Virginia
-
Roanoke, Virginia, United States, 24017
- Recruiting
- Roanoke Health Center
-
Contact:
- Christine Hernández, MPH, MPM, CPHQ
- Phone Number: 828-280-5723
- Email: christina.hernandez@ppsat.org
-
Contact:
- Matthew Zerden, MD, MPH
- Phone Number: 617-935-2394
- Email: matthew.zerden@ppsat.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be 18 years old or older
- Read and speak English
- Know the date of their last menstrual period within 2 days
- Have a period that is late by up to 21 days
- Must have had regular periods in the last 4 months
- Does not want to be pregnant
- Does not want to verify pregnancy status
- Understand that if they are pregnant, the pills will end their pregnancy
- Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
Exclusion Criteria:
- Under 18 years old
- Does not read and speak English
- Does not know the date of their last menstrual period within 2 days
- Has not had regular periods in the last 4 months
- Wants to be pregnant
- Wants to verify pregnancy status
- Does not display understanding that if they are pregnant, the pills will end their pregnancy
- Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Participants
Study participants will be persons who have late period of up to 21 days
|
Study participants are given mifepristone and misoprostol for menstrual regulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interest in period pills
Time Frame: Documented at Enrollment Survey
|
The proportion of the clinic-going population that may be interested in a period pill to bring on a late period and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.
|
Documented at Enrollment Survey
|
|
Satisfaction with period pills
Time Frame: Documented at Follow-up Survey, 4 weeks after drug administration
|
The proportion of participants reporting being "satisfied" or "very satisfied" with the period pills on a five-point Likert scale at follow-up (4 weeks).
|
Documented at Follow-up Survey, 4 weeks after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of period pills
Time Frame: Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.
|
The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period.
|
Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ushma D Upadhyay, PhD, MPH, University of California, San Francisco
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-45282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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