Adenomyosis and Ulipristal Acetate

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Brief Title

Adenomyosis and Ulipristal Acetate

Official Title

Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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)

Secondary Outcome

 Evolution of the PBAC score over 28 days compared to pre-treatment score (J1)

Condition

Adenomyosis

Intervention

Ulipristal acetate

Study Arms / Comparison Groups

 Ulipristal acetate
Description:  ESMYA® : 2 tablets of 5mg per day during 3 months, per os

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

May 2015

Completion Date

December 2017

Primary Completion Date

December 2017

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.
      

Gender

Female

Ages

30 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Hervé FERNANDEZ, MD, PhD, +33(0)145217701, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02587000

Organization ID

P141201

Secondary IDs

2014-004403-75

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 Gedeon Richter Ltd.

Study Sponsor

Hervé FERNANDEZ, MD, PhD, Principal Investigator, AP-HP, Bicêtre Hospital


Verification Date

October 2016