Period Pills for Menstrual Regulation: A New Reproductive Health Option

NCT07671989 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 25-45282
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.

Conditions

Menstrual Regulation; Menstrual Health Intervention

Keywords

late period; missed period; mestruation

Outcome Measures

Primary Outcomes (2)

• Interest in period pills

  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

  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 Outcomes (1)

• Efficacy of period pills

  Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.

Study Arms (1)

Study Participants

EXPERIMENTAL

Study participants will be persons who have late period of up to 21 days

Drug: Mifepristone + Misoprostol

Interventions

Mifepristone + Misoprostol DRUG

Study participants are given mifepristone and misoprostol for menstrual regulation.

Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

UCSF Advancing New Standards in Reproductive Health (ANSIRH)

Oakland, California, 94612, United States

ACTIVE NOT RECRUITING

Roanoke Health Center

Roanoke, Virginia, 24017, United States

RECRUITING

Related Links

• Period Pills Study Website

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ushma D Upadhyay, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ushma D Upadhyay, PhD, MPH

CONTACT

415-353-4626; ushma.upadhyay@ucsf.edu

Jennifer Ko, MLIS

CONTACT

415-353-9113; jennifer.ko@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

US (2)