Adenomyosis and Ulipristal Acetate (NCT02587000) | Clinical Trial Compass
CompletedPhase 2
Adenomyosis and Ulipristal Acetate
France26 participantsStarted 2015-06-16
Plain-language 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.
Who can participate
Age range30 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sel…
What they're measuring
1
Percentage of patients with a control uterine bleeding estimated by a score of Pictorial Blood-loss Assessment Chart (PABC) < 75 of 28 days to the discontinuation of the study (S13)