Adenomyosis and Ulipristal Acetate

NCT02587000 | Completed Phase 2

• 2 other identifiers: P1412012014-004403-75
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis

Keywords

adenomyosis; ulipristal acetate; sonography; Magnetic resonance imaging [MRI]; Pictorial Blood-loss Assessment Chart [PBAC]

Outcome Measures

Primary Outcomes (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)

  after 12 weeks of treatment

Secondary Outcomes (14)

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

  at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment

• Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days

  at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)

• 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;

  at Day 29

• percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days

  to week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)

• Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea

  for the first day of amenorrhea after the treatment

Study Arms (2)

Ulipristal acetate

ACTIVE COMPARATOR

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

Drug: Ulipristal acetate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ulipristal acetate DRUG

Also known as: ESMYA®

Ulipristal acetate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hervé FERNANDEZ, MD, PhD

  AP-HP, Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: October 27, 2015
• Study Start: June 16, 2015
• Primary Completion: February 2, 2018
• Study Completion: March 17, 2020
• Last Updated: September 27, 2022

Record last verified: 2016-09

Locations

FR (1)