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Hormones or surgery? new study tackles rectal endometriosis dilemma

NCT ID NCT01973816

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at two ways to manage rectal endometriosis in women aged 35-50 who do not plan to get pregnant. One group received hormone therapy for 24 months, while the other had surgery followed by hormones. The goal was to see which approach leads to better digestive function and quality of life. The trial involved 78 women across 11 French hospitals and followed them for 2 years.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

78 people

The number who actually took part.

Started

Sep 2014

Finished

Oct 2022

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

35 to 50 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: * Age 35-50 * No menopause * Digestive complaints: defecation pain, dyskesia, diarrhea, constipation, rectorrhage * Imaging assessment revealing deep endometriosis involving at least the muscular rectal layer * No intention to get pregnant during the following 24 months * Negative urinary pregnancy test * Affiliated to the French Social Security System Exclusion Criteria: * Pregnant women or during the breastfeeding * Pregnancy intention or lack of efficient contraception * Unexpected rectal endometriosis intraoperatively revealed * Refus of one of treatments planned in the two arms * Severe disease requiring surgical treatment in emergency (bowel occlusion, ureteral stenosis or hydronephrosis), severe dyspareunia * Contraindications to hormonal treatment or surgery * Major thromboembolic factors * Antecedents of inflammatory bowel diseases, cancer or colorectal resection * Vaginal hemorrhage with undetermined etiology

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Conditions

The condition(s) this trial relates to.

endometriosis

As listed by the trial registrant

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

Endometriosis

Contacts and locations

Locations

  • CHU d'AMIENS

    Amiens, 80054, France

  • CHU de DIJON

    Dijon, 21079, France

  • CHU de STRASBOURG STRASBOURG

    Strasbourg, 67000, France

  • Chi Poissy-St Germain En Laye Poissy

    Poissy, 78103, France

  • Clinique Gynécologique CHRU de LILLE

    Lille, 59037, France

  • Clinique Gynécologique et Obstétricale

    Rouen, 76031, France

  • Hôpital de TENON

    Paris, 75020, France

  • Hôpital du CHESNAY

    Le Chesnay, 78157, France

  • Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac

    Clermont-Ferrand, 63000, France

  • Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE

    Le Kremlin-Bicêtre, 94270, France

  • Service de Gynécologie-Obstétrique CHU de NIMES

    Nîmes, 39900, France

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