100 Participants NeededMy employer runs this trial

Mifepristone + Misoprostol for Menstrual Regulation

(Period Pills Trial)

Recruiting at 1 trial location
UD
JK
Overseen ByJennifer Ko, MLIS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two medications, mifepristone and misoprostol, to regulate missed menstrual periods. It targets individuals with a period delayed by up to 21 days who do not wish to be pregnant. Participants should know the date of their last period and have had regular cycles for the past four months. This trial does not suit those with certain health conditions, such as bleeding disorders or allergies to the medications involved. As a Phase 4 trial, this research involves an FDA-approved treatment and focuses on understanding its benefits for more patients.

What is the safety track record for mifepristone and misoprostol?

Previous studies have shown that the combination of mifepristone and misoprostol is safe for managing menstrual cycles. Research indicates that side effects are generally mild and uncommon. Some individuals might experience nausea, stomach pain, or tiredness, but these reactions are usually mild and manageable.

Data from one study showed that bleeding successfully started in over 97% of participants, with mild side effects. Another study found that lower doses of mifepristone resulted in fewer side effects and a quicker return to a regular menstrual cycle.

When used as directed, the FDA considers mifepristone safe, demonstrating its reliability. Overall, the combination treatment is well-tolerated, with any side effects being relatively mild.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Mifepristone and Misoprostol for menstrual regulation because it offers a new approach to managing delayed periods. Unlike the standard of care options that often involve hormonal therapies, this combination works by using Mifepristone to block progesterone, a hormone necessary for pregnancy continuation, and Misoprostol to induce uterine contractions. This mechanism is particularly promising as it can effectively regulate menstruation up to 21 days late, potentially providing a more timely solution for those experiencing delays. The excitement lies in its ability to offer a non-invasive, efficient alternative with rapid results compared to traditional hormonal treatments.

What is the effectiveness track record for Mifepristone + Misoprostol in menstrual regulation?

Research has shown that using mifepristone and misoprostol together effectively manages menstrual cycles. Studies have found that these medications can help women who have missed their period return to a non-pregnant state. One study reported a very high success rate in achieving this outcome. Additionally, mifepristone and misoprostol are well-known for safely ending early pregnancies, further supporting their use in regulating menstruation. This combination is considered safe and effective when used correctly.12367

Who Is on the Research Team?

UD

Ushma D Upadhyay, PhD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people who want to use medication (mifepristone and misoprostol) to help regulate their periods. Participants are those seeking menstrual regulation, but specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

Have a period that is late by up to 21 days
I do not have any conditions or allergies that prevent me from safely taking mifepristone or misoprostol.
I am 18 years old or older.
See 6 more

Exclusion Criteria

Does not read and speak English
I am under 18 years old.
Wants to verify pregnancy status
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a combination of mifepristone and misoprostol for menstrual regulation

Up to 21 days

Follow-up

Participants are monitored for satisfaction and efficacy of the period pills

4 weeks
Follow-up survey at 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mifepristone + Misoprostol

Trial Overview

The study observes the effects of taking mifepristone followed by misoprostol as a way to manage or regulate menstruation. It does not assign treatments randomly; participants choose this method themselves.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Study ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26405260/

Feasibility and effectiveness of unintended pregnancy ...

Low-dose mifepristone and misoprostol administered at the time of expected menstruation was effective and safe in maintaining or restoring non-pregnant status,

Menstrual induction with mifepristone and misoprostol

Mifepristone followed by the administration of a prostaglandin has been shown to be very effective in menstrual regulation [64,65]. Single doses of mifepristone ...

Feasibility and effectiveness of unintended pregnancy ...

Low-dose mifepristone and misoprostol administered at the time of expected menstruation was effective and safe in maintaining or restoring non-pregnant status, ...

Key Facts About Missed Period Pills Every Woman Should Know

it should not be taken past 10 weeks of pregnancy, Bleeding lasts for a median of 12 days but can last anywhere from 4 and 43 days. last between 2-8 weeks.

Questions and Answers on Mifepristone for Medical ...

Mifepristone, when used together with another medicine called misoprostol, is used to end an intrauterine pregnancy through ten weeks gestation ...

Abortion Safety and Use with Normally Prescribed ...

Abortion safety outcomes remained stable during the period before mifepristone had become available and during the period after its ...

Effectiveness and Safety of Lower Doses of Mifepristone ...

Moreover, the lower doses of mifepristone led to shorter vaginal bleeding period, the return of menses on the expected date, and fewer side effects.