Missed Period Pill Study

NCT04940013 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 20-30048
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menstrual Irregularity; Menstrual Regulation

Keywords

late period; missed period; mensturation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Efficacy of missed period pills

  Documented at the second study visit, through study completion at around 4 weeks after drug adminstration

Study Arms (1)

Study participants

OTHER

Study participants will be persons who have late period of up to 14 days

Drug: Misoprostol

Interventions

Misoprostol DRUG

Study participants are given misoprostol alone 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

Fresno, California, 93701, United States

Location

Related Links

• Missed Period Pill Study Enrollment Website

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ushma Upadhyay, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 25, 2021
• Study Start: October 25, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)