Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2015-06-16
2020-03-17
Brief Summary
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Detailed Description
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48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ulipristal acetate
ESMYA® : 2 tablets of 5mg per day during 3 months, per os
Ulipristal acetate
Placebo
2 tablets of 5mg per day during 3 months, per os
Placebo
Interventions
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Ulipristal acetate
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Accepting to give consent informed in writing,
* Suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated with pain)
* Diagnosis information, confirmed the adenomyosis (T2-weighted) MRI and/or transvaginal ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding (PBAC) \> 100 from J1 to J8 of the menstruation before the visit of inclusion,
* With an index of body mass (IMC) ≥18 and \< 40,
* Using a reliable method of non-hormonal contraception (non-hormonal intrauterine device (IUDs), sexual abstinence, diaphragm, condoms or vasectomy by the partner, or having undergone a surgical sterilization),
* Willing and able to complete auto-questionnaires in french
* Had no difficulties to understand and communicate with the investigator and his representatives
* Affiliation to a social security or assign.
Exclusion Criteria
* Patient with a history of surgery (other than a caesarean or a cervical conization) uterus, ablation endometrial or uterine artery embolization,
* With other than the endometriosis endometrial pathology,
* Suffering of myoma of type 0, 1, 2 or 3,
* Requiring a transfusion or having a ≤6g/dL hemoglobin
* Existence of systemic coagulation,
* History of thromboembolism
* Progestagen taking severe disorders in the month preceding the tour selection, and corticosteroids and aspirin in the previous week,
* Existence of Pathology renal, respiratory or cardiac severe or progressive,
* Having a disturbed liver function (defined by the aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT), γGlutamylTranspeptidase, alkaline phosphatase or total bilirubin above 2 times the upper limit of normal),
* Existence or suspicion of malignancy,
* Considering pregnancy in the coming year,
* Pregnant patient or nursing
* Any clinical condition that the investigator considers incompatible with the conduct of the study in terms of acceptable security,
* Participation in courses at another clinical study
* Patient whose accession to the test procedures may be insufficient or for which a long term follow-up seems difficult to achieve
* Person under authorship or curators under safeguard of justice
* History of hypersensitivity to the ulipristal or any of the excipients of ESMYA ® 5 mg tablet.
30 Years
50 Years
FEMALE
No
Sponsors
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Gedeon Richter Ltd.
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Hervé FERNANDEZ, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Bicêtre Hospital
Locations
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AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, , France
Countries
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Other Identifiers
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2014-004403-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P141201
Identifier Type: -
Identifier Source: org_study_id
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