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Adenomyosis and Ulipristal Acetate (FRA-IIT-UPA)

Primary Purpose

Adenomyosis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ulipristal acetate
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis focused on measuring adenomyosis, ulipristal acetate, sonography, Magnetic resonance imaging [MRI], Pictorial Blood-loss Assessment Chart [PBAC]

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • AP-HP, Bicêtre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ulipristal acetate

Placebo

Arm Description

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

2 tablets of 5mg per day during 3 months, per os

Outcomes

Primary Outcome Measures

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 Measures

Evolution of the PBAC score over 28 days compared to pre-treatment score (J1)
Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days
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;
percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days
Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea
Evolution of pain through a Visual scale analogue between J1 and S5 (J29) S13 (J85) and M6 (S26 S28),
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
Evolution quality of life questionnaire with Uterine Fibroid Symptom and health related Quality of Life (UFS - QOL) questionnaire
Evolution of anemia by hemoglobin and ferritin concentration and coagulation by the CAW
Evaluation of the adenomyosis by MRI or ultrasound transvaginal : existence/absence, focal length/diffuse, shallow/deep
blood pressure and heart rate, respiratory rate
Number of participants with adverse events and their grades as assessed by CTCAE v4.0
biological examinations: hemoglobin, ferritin, TCA.
Safety assessment
Frequency of flashes of heat, headache, thickening of the endometrium, uterine bleeding, ovarian cyst.

Full Information

First Posted
May 29, 2015
Last Updated
September 26, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02587000
Brief Title
Adenomyosis and Ulipristal Acetate
Acronym
FRA-IIT-UPA
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 16, 2015 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
Keywords
adenomyosis, ulipristal acetate, sonography, Magnetic resonance imaging [MRI], Pictorial Blood-loss Assessment Chart [PBAC]

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulipristal acetate
Arm Type
Active Comparator
Arm Description
ESMYA® : 2 tablets of 5mg per day during 3 months, per os
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 tablets of 5mg per day during 3 months, per os
Intervention Type
Drug
Intervention Name(s)
Ulipristal acetate
Other Intervention Name(s)
ESMYA®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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)
Title
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
Title
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)
Title
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
Title
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)
Title
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)
Title
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)
Title
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)
Title
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
Title
blood pressure and heart rate, respiratory rate
Time Frame
Before the treatment and up to 6 months after beginning of the treatment
Title
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
Title
biological examinations: hemoglobin, ferritin, TCA.
Description
Safety assessment
Time Frame
Before the treatment and up to 6 months after beginning of the treatment
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé FERNANDEZ, MD, PhD
Organizational Affiliation
AP-HP, Bicêtre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Bicêtre Hospital
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

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Adenomyosis and Ulipristal Acetate

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