Missed Period Pill Study (MPP)
Primary Purpose
Menstrual Regulation, Menstrual Irregularity
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional other trial for Menstrual Regulation focused on measuring late period, missed period, mensturation
Eligibility Criteria
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.
Sites / Locations
- University of California, San Francisco (Berkeley)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study participants
Arm Description
Study participants will be persons who have late period of up to 14 days
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04940013
First Posted
June 11, 2021
Last Updated
January 5, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04940013
Brief Title
Missed Period Pill Study
Acronym
MPP
Official Title
Assessing the Acceptability of Using Misoprostol Alone for Menstrual Regulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Missed Period Pill Study is a prospective observational study among people who decide to use misoprostol alone for menstrual regulation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Regulation, Menstrual Irregularity
Keywords
late period, missed period, mensturation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study participants
Arm Type
Other
Arm Description
Study participants will be persons who have late period of up to 14 days
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Study participants are given misoprostol alone for menstrual regulation.
Primary Outcome Measure Information:
Title
Interest in missed period pills
Description
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.
Time Frame
Documented at Enrollment Survey
Title
Satisfaction with missed period pills
Description
The proportion of participants reporting being "satisfied" or "very satisfied" with the missed period pills on a five-point Likert scale at 4 weeks.
Time Frame
Documented at Follow-up Survey, 4 weeks after drug administration
Secondary Outcome Measure Information:
Title
Efficacy of missed period pills
Description
The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period.
Time Frame
Documented at the second study visit, through study completion at around 4 weeks after drug adminstration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ushma Upadhyay, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco (Berkeley)
City
Berkeley
State/Province
California
ZIP/Postal Code
94702
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.periodpillstudy.org/
Description
Missed Period Pill Study Enrollment Website
Learn more about this trial
Missed Period Pill Study
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