Adenomyosis and Ulipristal Acetate

checkorphan
Learn more about:
Adenomyosis
Related Clinical Trial
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis Long-term Use of Mifepristone in the Treatment of Adenomyosis Radiofrequency Ablation of Adenomyosis Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis The Effect of Adenomoyosis on Pregnancy Outcomes Observational Study of Patients Suffering From Endometriosis and Adenomyosis Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis Quality of Life After Hysterectomy (AdenoQOL) Low Molecular Weight Heparin on the Adenomyosis Patients’IVF-ET Outcome Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI Clinical and Molecular Study of Endometriosis and Adenomyosis Surgical Success After Laparoscopic vs Abdominal Hysterectomy Electronic Catheter Stethoscope Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Uterine Artery Embolization for Symptomatic Fibroids Oxytocin in MRI-HIFU To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy Effect of Addition of Steroids on Duration of Analgesia Paracervical Block in Laparoscopic Hysterectomy Use of Dexamethasone in Uterine Artery Embolization Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) Dienogest for Treatment of Adenomyotic Uteri Health-Related QoL Among Women Receiving Hysterectomy in NTUH Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis Adenomyosis and Ulipristal Acetate Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis LNG-IUS for Treatment of Dysmenorrhea Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Adenomyosis: Genomic Mechanisms and Biological Response What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis A Prospective Study of Diagnostic Accuracy of Ultrasound Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis A Multi-omics Study of Adenomyosis Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis Levonorgestrel Intrauterine System and Adenomyosis Validation of the Adenomyosis Calculator Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Norwegian Adenomyosis Study III: Peristalsis Histopathological Diagnosis of Adenomyosis Norwegian Adenomyosis Study I Vaginal Bromocriptine for Treatment of Adenomyosis Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

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