Menstrual RegulationPhase 4MPPNCT04940013
Missed Period Pill Study
A Phase 4 study testing Misoprostol in people with Menstrual Regulation and Menstrual Irregularity, run by University of California, San Francisco at 1 site in United States.
Trial summary
The Missed Period Pill Study is a prospective observational study among people who decide to use misoprostol alone for menstrual regulation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Regulation, Menstrual Irregularity
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
Fresno, California, 93701
About this study
Official 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.
Read the 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.
- Conditions
- Menstrual Regulation, Menstrual Irregularity
- Being tested
- Misoprostol
- Keywords
- late period, missed period, mensturation
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Study participants are given misoprostol alone for menstrual regulation.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Other | Study participants will be persons who have late period of up to 14 days Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Documented at Follow-up Survey, 4 weeks after drug administration
Secondary outcomes (1)
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.
Measured: Documented at the second study visit, through study completion at around 4 weeks after drug adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start25 Oct 2021
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Why it stopped: Lack of successful recruitment and loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual RegulationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ushma Upadhyay, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940013
- Sponsor's protocol ID
- 20-30048
- Acronym
- MPP
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2021
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Acceptability of Using Misoprostol Alone for Menstrual Regulation
- ClinicalTrials.gov ID
- NCT04940013
- Acronym / sponsor ID
- MPP / 20-30048
- Conditions
- Menstrual Regulation, Menstrual Irregularity
- Keywords
- late period, missed period, mensturation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of successful recruitment and loss of funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Other | Drug: MisoprostolStudy participants will be persons who have late period of up to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolStudy participants are given misoprostol alone for menstrual regulation. | Drug | Study participants |
Primary outcome
Interest in missed period pills
Time frame: Documented at Enrollment Survey
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
Time frame: Documented at Follow-up Survey, 4 weeks after drug administration
The proportion of participants reporting being "satisfied" or "very satisfied" with the missed period pills on a five-point Likert scale at 4 weeks.
1 secondary outcome
Efficacy of missed period pills
Time frame: Documented at the second study visit, through study completion at around 4 weeks after drug adminstration
Results and safety
The study was stopped early (reason given: Lack of successful recruitment and loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Missed Period Pill Study Enrollment WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ushma Upadhyay, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Menstrual Regulation and Menstrual Irregularity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of successful recruitment and loss of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interest in missed period pills (time frame: Documented at Enrollment Survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.