Mifepristone + Misoprostol
DrugStudy participants are given mifepristone and misoprostol for menstrual regulation.
NCT Number: NCT07671989
The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
UCSF Advancing New Standards in Reproductive Health (ANSIRH), Oakland, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study participants are given mifepristone and misoprostol for menstrual regulation.
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.
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).
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.
Contact information is provided by the study sponsor or research team.
Jennifer Ko, MLIS
CONTACT
Ushma D Upadhyay, PhD, MPH
CONTACT
University of California, San Francisco
Other
Acronym: Period Pills
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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