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 range

30 Years – 50 Years

Sex

FEMALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Timeframe: after 12 weeks of treatment

Trial details

NCT IDNCT02587000

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-02

View on ClinicalTrials.gov More Adenomyosis trials