Clinical trial: Adenomyosis and Ulipristal Acetate (NCT02587000)

Eligibility 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.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction