Mifepristone + Misoprostol for Menstrual Regulation
(Period Pills 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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a combination of mifepristone and misoprostol for menstrual regulation
Follow-up
Participants are monitored for satisfaction and efficacy of the period pills
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
Study participants will be persons who have late period of up to 21 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Citations
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.
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