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Adenomyosis and Ulipristal Acetate (FRA-IIT-UPA)

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ClinicalTrials.gov Identifier: NCT02587000
Recruitment Status : Unknown
Verified October 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Adenomyosis Drug: Ulipristal acetate Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ulipristal acetate
ESMYA® : 2 tablets of 5mg per day during 3 months, per os
Drug: Ulipristal acetate
Other Name: ESMYA®

Placebo Comparator: Placebo
2 tablets of 5mg per day during 3 months, per os
Drug: Placebo



Primary Outcome Measures :
  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) [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Evolution of the PBAC score over 28 days compared to pre-treatment score (J1) [ Time Frame: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment ]
  2. Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days [ Time Frame: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  3. Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of control of uterine bleeding; [ Time Frame: at Day 29 ]
  4. percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days [ Time Frame: to week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  5. Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea [ Time Frame: for the first day of amenorrhea after the treatment ]
  6. Evolution of pain through a Visual scale analogue between J1 and S5 (J29) S13 (J85) and M6 (S26 S28), [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  7. Evolution of analgesics using between each visit (number of days of treatment and the percentage of patients without analgesic over each period of 28 days of collection of the PBAC) and by bearing the information provided by the investigator [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  8. Evolution quality of life questionnaire with Uterine Fibroid Symptom and health related Quality of Life (UFS - QOL) questionnaire [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  9. Evolution of anemia by hemoglobin and ferritin concentration and coagulation by the CAW [ Time Frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1) ]
  10. Evaluation of the adenomyosis by MRI or ultrasound transvaginal : existence/absence, focal length/diffuse, shallow/deep [ Time Frame: Before the treatment and 6 months after beginning of the treatment ]
  11. blood pressure and heart rate, respiratory rate [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]
  12. Number of participants with adverse events and their grades as assessed by CTCAE v4.0 [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]
  13. biological examinations: hemoglobin, ferritin, TCA. [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]
    Safety assessment

  14. Frequency of flashes of heat, headache, thickening of the endometrium, uterine bleeding, ovarian cyst. [ Time Frame: Before the treatment and up to 6 months after beginning of the treatment ]


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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587000


Contacts
Contact: Hervé FERNANDEZ, MD, PhD +33(0)145217701 herve.fernandez@bct.aphp.fr

Locations
France
AP-HP, Bicêtre Hospital Recruiting
Le Kremlin Bicêtre, France, 94275
Contact: Hervé FERNANDEZ, MD, PhD    +33(0)145217701    herve.fernandez@bct.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Gedeon Richter Ltd.
Investigators
Principal Investigator: Hervé FERNANDEZ, MD, PhD AP-HP, Bicêtre Hospital

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02587000     History of Changes
Other Study ID Numbers: P141201
2014-004403-75 ( EudraCT Number )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: October 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
adenomyosis
ulipristal acetate
sonography
Magnetic resonance imaging [MRI]
Pictorial Blood-loss Assessment Chart [PBAC]

Additional relevant MeSH terms:
Adenomyosis
Uterine Diseases
Genital Diseases, Female