Adenomyosis and Ulipristal Acetate (FRA-IIT-UPA)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Adenomyosis

Treatments

Drug: Placebo

Drug: Ulipristal acetate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02587000

P141201

2014-004403-75 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 patients

Sex

Female

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

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.