Menstrual Irregularity Clinical Trial
— MPPOfficial title:
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
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