EndometriosisPhase 3MESURENCT01973816
MEdical Versus SUrgical Treatments of Rectal Endometriosis
A Phase 3 study testing Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;, rectal shaving; rectal disc excision; colorectal resection and Cyproterone acetate 50 mg; estradiol 0.5% percutaneous in people with Endometriosis, run by University Hospital, Rouen at 11 sites in France.
Trial summary
The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;, rectal shaving; rectal disc excision; colorectal resection and Cyproterone acetate 50 mg; estradiol 0.5% percutaneous
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 11 sitesFrance
- Study dates
- 9 Sep 2014to 11 Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Major thromboembolic factors
- Antecedents of inflammatory bowel diseases, cancer or colorectal resection
- Vaginal hemorrhage with undetermined etiology
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU d'AMIENS
Amiens, 80054
Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac
Clermont-Ferrand, 63000
CHU de DIJON
Dijon, 21079
Hôpital du CHESNAY
Le Chesnay, 78157
Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE
Le Kremlin-Bicêtre, 94270
Clinique Gynécologique CHRU de LILLE
Lille, 59037
Service de Gynécologie-Obstétrique CHU de NIMES
Nîmes, 39900
Hôpital de TENON
Paris, 75020
Chi Poissy-St Germain En Laye Poissy
Poissy, 78103
Clinique Gynécologique et Obstétricale
Rouen, 76031
CHU de STRASBOURG STRASBOURG
Strasbourg, 67000
About this study
Official title: Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery
The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Are included women from 35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of the rectum and not having pregnancy intention.
The main outcome concerns the quality of digestive function 24 after the onset of the treatment, assessed using a composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.
Read more
Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel movements, anal incontinence, postoperative dysuria, Biberoglou \& Behrman score, quality of life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score, the rate of postoperative complications, medical treatment adverse outcomes, the rate of additional endoscopic and surgical procedures.
The randomization is central, once the physician asses the diagnosis, explain the study's principle and rece In the arm A, the patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months.
In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.
The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24 months. The length of the follow up is 24 months. The patients have 8 visits in the arm A, and 7 visits in the arm B.
Eleven French tertiary referral centres will enrol patients in the trial.
- Conditions
- Endometriosis
- Being tested
- Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;, rectal shaving; rectal disc excision; colorectal resection, Cyproterone acetate 50 mg; estradiol 0.5% percutaneous, Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral
- Keywords
- deep endometriosis;, rectal endometriosis;, rectal shaving;, colorectal resection;, bowel endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;Drug
Triptoreline 11.25 administered for 3 months, two consecutive cures Estradiol administered daily for 6 months
rectal shaving; rectal disc excision; colorectal resectionProcedure or surgery
Cyproterone acetate 50 mg; estradiol 0.5% percutaneousDrug
Daily intake for 18 months
Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oralDrug
Daily intake during 24 months
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment | Experimental | The patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months. Receives: Drug: Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;; Drug: Cyproterone acetate 50 mg; estradiol 0.5% percutaneous |
| Surgical | Active comparator | The patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months. Receives: Procedure: rectal shaving; rectal disc excision; colorectal resection; Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative digestive function
Composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.
Measured: 24 months
Secondary outcomes (1)
Unfavorable digestive functional outcome
Presence of severe constipation (<1 stool/5D), increased frequency of daily bowel movements (>=3 stools/D), anal incontinence, postoperative dysuria
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study start9 Sep 2014
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973816
- Sponsor's protocol ID
- 2013/001/HP
- Acronym
- MESURE
- Status last verified
- Jan 2026
- First submitted
- 25 Oct 2013
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery
- ClinicalTrials.gov ID
- NCT01973816
- Acronym / sponsor ID
- MESURE / 2013/001/HP
- Conditions
- Endometriosis
- Keywords
- deep endometriosis;, rectal endometriosis;, rectal shaving;, colorectal resection;, bowel endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Are included women from 35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of the rectum and not having pregnancy intention.
The main outcome concerns the quality of digestive function 24 after the onset of the treatment, assessed using a composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.
Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel movements, anal incontinence, postoperative dysuria, Biberoglou \& Behrman score, quality of life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score, the rate of postoperative complications, medical treatment adverse outcomes, the rate of additional endoscopic and surgical procedures.
The randomization is central, once the physician asses the diagnosis, explain the study's principle and rece In the arm A, the patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months.
In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.
The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24 months. The length of the follow up is 24 months. The patients have 8 visits in the arm A, and 7 visits in the arm B.
Eleven French tertiary referral centres will enrol patients in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment | Experimental | Drug: Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;, Drug: Cyproterone acetate 50 mg; estradiol 0.5% percutaneousThe patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months. |
| Surgical | Active comparator | Procedure: rectal shaving; rectal disc excision; colorectal resection, Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oralThe patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;Triptoreline 11.25 administered for 3 months, two consecutive cures Estradiol administered daily for 6 months | Drug | Medical treatment |
| rectal shaving; rectal disc excision; colorectal resection | Procedure or surgery | Surgical |
| Cyproterone acetate 50 mg; estradiol 0.5% percutaneousDaily intake for 18 months | Drug | Medical treatment |
| Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oralDaily intake during 24 months | Drug | Surgical |
Primary outcome
Postoperative digestive function
Time frame: 24 months
Composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.
1 secondary outcome
Unfavorable digestive functional outcome
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;, rectal shaving; rectal disc excision; colorectal resection and Cyproterone acetate 50 mg; estradiol 0.5% percutaneous in people with Endometriosis, run by University Hospital, Rouen at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative digestive function (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.