Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Ushma D Upadhyay, PhD, MPH (ucsf)
Headshot of Ushma D Upadhyay
Ushma D Upadhyay

Description

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.

Details

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.

Keywords

Menstrual Regulation, Menstrual Health Intervention, late period, missed period, mestruation, Mifepristone, Misoprostol, Mifepristone + Misoprostol

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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)

Locations

  • UCSF Advancing New Standards in Reproductive Health (ANSIRH) in progress, not accepting new patients
    Oakland California 94612 United States
  • Roanoke Health Center accepting new patients
    Roanoke Virginia 24017 United States

Lead Scientist at University of California Health

  • Ushma D Upadhyay, PhD, MPH (ucsf)
    Ushma Upadhyay, PhD, MPH is a public health scientist trained in epidemiology and demography. She is in the Department of Obstetrics, Gynecology, & Reproductive Sciences and is also core faculty of Advancing New Standards in Reproductive Health (ANSIRH). Dr. Upadhyay was born and raised near Boston, Massachusetts.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Period Pills Study Website
ID
NCT07671989
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated