Misoprostol for Menstrual Irregularities

(MPP Trial)

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the drug Misoprostol (Cytotec) for menstrual irregularities?

Misoprostol is known to be effective for various gynecological issues, such as managing miscarriages and inducing labor, which suggests it may help with menstrual irregularities due to its ability to influence uterine activity. ^{1 2 3 4 5}

Is Misoprostol generally safe for humans?

The provided research articles do not contain specific safety data on Misoprostol or its other names like Cytotec. They focus on other hormonal treatments and their safety profiles. ^{6 7 8 9 10}

How is the drug misoprostol unique for treating menstrual irregularities?

Misoprostol is unique because it is a prostaglandin E1 analogue that is rapidly absorbed both orally and vaginally, making it versatile in administration. Although not originally intended for menstrual irregularities, it has been widely used for various gynecological purposes due to its effectiveness and low cost. ^{1 2 5 11 12}

Research Team

Ushma Upadhyay, PhD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

Read and speak English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Instability of misoprostol tablets stored outside the blister: a potential serious concern for clinical outcome in medical abortion. [2020]

2. France pubmed.ncbi.nlm.nih.gov

[Rectal administration of misoprostol for delivery induced hemorrhage. Preliminary study]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Two regimens of misoprostol for treatment of incomplete abortion. [2013]

4. Bulgaria pubmed.ncbi.nlm.nih.gov

[The efficacy of the misoprostol in cases of abnormal and pathologic hypotonic hemorrhage in the early puerperium]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Vaginal misoprostol for cervical ripening and induction of labour. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Contraceptive action of continuous low doses of norgestrel. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine system--the discontinuing story. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The levonorgestrel-releasing intrauterine system: an updated review of the contraceptive and noncontraceptive uses. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Progestogens: a look at the "other" hormone. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Improving cycle control in progestogen-only contraceptive pill users by intermittent treatment with a new anti-progestogen. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Vaginal misoprostol for cervical ripening and induction of labour. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Vaginal misoprostol for cervical ripening and induction of labour. [2020]