Adenomyosis and Ulipristal Acetate

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Gedeon Richter Ltd.
• Treatments: Ulipristal acetate

Criteria

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.