Misoprostol for Menstrual Irregularities

(MPP Trial)

Not currently recruiting at 2 trial locations

Overseen By Jennifer Ko

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Ectopic pregnancy, Irregular menses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how effectively the medication misoprostol regulates periods delayed by up to 14 days. It targets individuals with recently regular periods who do not wish to be pregnant. Participants should know the date of their last period and be willing to consider an abortion if the medication proves ineffective. The study aims to assess the effectiveness and safety of using misoprostol alone for menstrual regulation. Those who have missed a period and are considering this option might be suitable candidates. As a Phase 4 trial, this research focuses on understanding how this FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not have contraindications to misoprostol, so it's best to discuss your current medications with the trial team.

What is the safety track record for Misoprostol?

Research has shown that misoprostol is generally safe for humans and has been used in various medical situations. In past studies, some women experienced mild side effects such as light bleeding and cramps. Moderate side effects included nausea, stomach pain, fever, vomiting, and fatigue.

It is important to note that misoprostol can cause miscarriage or birth defects if taken during pregnancy, so a negative pregnancy test is necessary before starting treatment. Overall, evidence suggests that while some side effects exist, misoprostol is well-tolerated for its intended uses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for menstrual irregularities, which often include hormonal therapies or nonsteroidal anti-inflammatory drugs (NSAIDs), Misoprostol works differently by promoting uterine contractions. This unique mechanism can help effectively regulate menstrual cycles, particularly for those with delayed periods. Researchers are excited about Misoprostol because it may offer a faster and potentially more direct approach to managing menstrual irregularities, providing relief for those who do not respond well to conventional treatments.

What is the effectiveness track record for Misoprostol in treating menstrual irregularities?

Research has shown that misoprostol effectively addresses various women's health issues, such as managing miscarriages and inducing labor. This trial will evaluate its potential for helping with irregular periods. In one study, over 92% of women experienced successful results with misoprostol when they had symptoms like abdominal pain and vaginal bleeding. Another study found that most women expelled their pregnancy within 24 hours after taking misoprostol, demonstrating its quick action. This treatment's successful use for other conditions supports its potential for managing late periods. ^{3 6 7 8 9}

Who Is on the Research Team?

Ushma Upadhyay, PhD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This study is for individuals who are at least 18 years old, have had regular menstrual periods over the last 4-6 months, and are up to 14 days late on their period. They must be able to read and speak English, know when their last period was within two days, and be open to an abortion if misoprostol doesn't regulate their cycle. Participants should not want to confirm pregnancy status or have any risk factors for ectopic pregnancy.

Inclusion Criteria

Does not want to be pregnant; understand that if they are pregnant, the pills will end their pregnancy

Know the date of their last menstrual period within 2 days

Agree to participate in the follow up visit/call

Exclusion Criteria

I have risk factors for an ectopic pregnancy, such as a history or symptoms.

I cannot take misoprostol due to health reasons.

Unknown date of last menstrual period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive misoprostol for menstrual regulation and undergo a pregnancy test

4 weeks

1 visit (in-person), 1 visit (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up survey

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Misoprostol

Trial Overview The Missed Period Pill Study is observing how people use misoprostol alone for regulating menstruation when they've missed a period but don't wish to confirm pregnancy. It's designed as a prospective observational study where participants' experiences with the drug will be monitored.

How Is the Trial Designed?

Group I: Study participants Experimental Treatment 1 Intervention

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

Misoprostol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cytotec for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in European Union as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in Canada as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a study involving five patients with severe delivery-induced hemorrhage due to uterine atony unresponsive to syntocinon, rectal administration of one misoprostol tablet effectively stopped the bleeding in less than 5 minutes for all patients.

No immediate side effects were observed, suggesting that misoprostol may be a safe and rapid intervention for managing severe hemorrhage in this context, warranting further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rectal administration of misoprostol for delivery induced hemorrhage. Preliminary study]. Shojai, R., Piéchon, L., d'Ercole, C., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611991/

Medication Abortion Safety and Effectiveness With ... Most participants experienced bleeding for less than 1 week (median, 4 days; IQR, 3-6 days) and expelled their pregnancy within 24 hours of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010782425001714

Interest in period pills in the United States: A nationally ... This study aims to develop a more generalizable understanding of interest in period pills in the United States, including specific sociodemographic subgroups.

3. withpower.com withpower.com/trial/phase-4-menstruation-disturbances-9-2021-69fca

Misoprostol for Menstrual Irregularities · Info for Participants Misoprostol is known to be effective for various gynecological issues, such as managing miscarriages and inducing labor, which suggests it may help with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1761999/

Factors Related to Successful Misoprostol Treatment for ... Overall success exceeds 92% in women who have localized abdominal pain within the last 24 hours, Rh-negative blood type, or the combination of vaginal bleeding ...

5. aafp.org aafp.org/pubs/afp/issues/2021/0415/p473.html

Mifepristone and Misoprostol for Early Pregnancy Loss ... Regimens using mifepristone and misoprostol are effective up to 84 days' gestation for early pregnancy loss, and up to 77 days' gestation for ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/019268s051lbl.pdf

Cytotec® misoprostol tablets WARNINGS ... Gynecological: Women who received Cytotec during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/misoprostol-oral-route/description/drg-20064805

Misoprostol (oral route) - Side effects & dosage This medicine can cause miscarriage, premature birth, or birth defects if taken during pregnancy. You will need to have a negative pregnancy ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539873/

Misoprostol - StatPearls - NCBI Bookshelf - NIH Patients should be advised to begin misoprostol treatment only on the second or third day of their next normal menstrual cycle. Warnings and ...

9. thealphacenter.org thealphacenter.org/missed-period-pills/

Key Facts About Missed Period Pills Every Woman Should Know Moderate reactions are reported to be nausea, abdominal pain, fever, vomiting, fatigue, headache, diarrhea, dizziness, GERD, insomnia, pelvic ...