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Can a common drug make fibroid surgery safer?

NCT ID NCT06882824

Disease control Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether taking misoprostol before myomectomy (surgery to remove uterine fibroids) can reduce blood loss during the operation. 80 women aged 18-43 with symptomatic fibroids will receive either misoprostol or a placebo before surgery. The goal is to see if this simple, well-tolerated drug can lower the risk of heavy bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
misoprostol
What this could lead to
If it works, this could provide a simple, well-tolerated drug to reduce bleeding during fibroid surgery, making the procedure safer.
What could go wrong
This is a small, early-stage trial (80 people) testing a drug already used for other purposes. The benefit may be small or not statistically significant, and side effects like cramps or nausea are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 43 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient aged 18 to 43 * Symptomatic myomas (bleeding, pain or infertility) * Indication for laparoscopic myomectomy Fibroma ≤ 10cm or number ≤ to 4 fibroids * Indication for myomectomy by laparotomy Fibroma \> 10cm, Number \> to 4 fibroids * OTAU possible intraoperatively (Clip on uterine artery and tourniquet placement) * Speak and understand French * Affiliated with a social security scheme. Exclusion Criteria: * History of major uterine surgery or myomectomy (excluding hysteroscopic myomectomy) * Allergy to misoprostol and lactose * Patients with hypersensitivity to misoprostol and/or other prostaglandins or to any of the product's excipients. * Patients taking aspirin or anti-coagulants * Patients with haemostasis disorders * Malnourished patients * Patients with hepatic or renal insufficiency * Pregnancy, suspected ectopic pregnancy and breast-feeding women. * Minors * Guardianship, curatorship, deprived of liberty, safeguard of justice

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical myofibroma uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myoma;uterus Myomectomy; surgical blood loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, Clermont-Ferrand, 63000, France

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