Adenomyosis and Ulipristal Acetate

Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis

Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

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.