Missed Period Pill Study (MPP)

Assessing the Acceptability of Using Misoprostol Alone for Menstrual Regulation

The Missed Period Pill Study is a prospective observational study among people who decide to use misoprostol alone for menstrual regulation.

Study Overview

• Status: Recruiting
• Conditions: Menstrual Irregularity; Menstrual Regulation
• Intervention / Treatment: Drug: Misoprostol

Detailed Description

As the number of state laws restricting access to abortion increases across the country, more creative methods are needed to support individuals in achieving their reproductive goals. Misoprostol alone for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. The goal of this research study is to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is missed. This study will aim to recruit 100 patients who have a missed period to address research questions that focus on the feasibility and acceptability of using misoprostol alone for menstrual regulation.

The study will require 1 study visit and 1 telehealth visit.

First study visit: A urine sample will be collected which will later undergo pregnancy testing. Participants will be given misoprostol along with instructions and information on what to expect. The participant will be required to return to the clinic 4 weeks later to provide another urine sample. The participant will not know the results of the first visit's pregnancy test at any point. The clinic staff member administering the participant's care will not know of the pregnancy test result while the participant is at the clinic.

Telehealth visit: The second visit will be by phone or video. The participant will conduct a pregnancy test and inform the research staff of the result. The participant will then be asked to answer questions on an online survey about their experience using misoprostol.

A variety of clinical and social science measures will be collected to assess the feasibility and acceptability of this traditional concept of menstrual regulation utilizing uterine evacuation with medications.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ushma Upadhyay, PhD, MPH; Phone Number: 510-986-8946; Email: ushma.upadhyay@ucsf.edu
• Study Contact Backup: Name: Jennifer Ko; Phone Number: 164 510-986-8990; Email: jennifer.ko@ucsf.edu

Study Locations

• United States
  • California
    • Fresno, California, United States, 93701
      • Recruiting
      • University of California, San Francisco
      • Contact: Tania Serna, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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 14 days
• Have had regular periods in the last 4-6 months
• Does not want to be pregnant; understand that if they are pregnant, the pills will end their pregnancy
• Be willing to have an abortion if the missed period pill does not work, and informed of potential for birth defects in any ongoing pregnancy
• Does not want to verify pregnancy status
• Does not have risk factors for ectopic pregnancy (history of ectopic pregnancy, recent vaginal bleeding or spotting, pelvic pain on one side, prior permanent contraception, or other tubal surgery)
• Does not have an IUD
• Does not currently use a contraceptive implant or injectable
• Does not have contraindications to misoprostol
• Agree to participate in the follow up visit/call

Exclusion Criteria:

• Participants who have contraindications to misoprostol
• Unknown date of last menstrual period
• Risk factors for ectopic pregnancy (history of ectopic pregnancy, recent vaginal bleeding or spotting, pelvic pain on one side, prior permanent contraception, or other tubal surgery)
• Irregular menses or any other condition that in the opinion of the Principal Investigator would compromise participant safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study participants; Study participants will be persons who have late period of up to 14 days	Drug: Misoprostol; Study participants are given misoprostol alone for menstrual regulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interest in missed period pills	The proportion of the clinic-going population that may be interested in a missed period pill and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.	Documented at Enrollment Survey
Satisfaction with missed period pills	The proportion of participants reporting being "satisfied" or "very satisfied" with the missed period pills on a five-point Likert scale at 4 weeks.	Documented at Follow-up Survey, 4 weeks after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of missed period pills	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 second study visit, through study completion at around 4 weeks after drug adminstration

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Ushma Upadhyay, PhD, MPH, University of California, San Francisco

Publications and helpful links

Helpful Links

• Missed Period Pill Study Enrollment Website

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: late period; missed period; mensturation
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 20-30048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes