Adenomyosis and Ulipristal Acetate

After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA.

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.

Inclusion criteria

• Not postmenopausal women aged 30 to 50,
• 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 hormonal oral contraceptive or with a hormonal intrauterine Device (IUD) contraceptive
• 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.