Uterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility. MedDRA version: 14.1 Level: LLT Classification code 10046801 Term: Uterine myoma Sy
Conditions
Interventions
Product Name: ulipristal acetate
Product Code: PGL4001
Pharmaceutical Form: Tablet
INN or Proposed INN: ulipristal acetate
CAS Number: 126784-99-4
Current Sponsor code: PGL4001
Other descriptive name
Sponsors
PregLem S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent prior to any study-related procedures. 2. Subject completed visit F – Follow-up of Pearl III extension study (PGL09-027) - without significant deviations. 3. Subject has no contra-indication to enter the long term extension study, based on the investigator’s judgment. 4. Females of childbearing potential are advised to practice a non-hormonal method of contraception among one of the following: a. Sexual abstinence b. Diaphragms c. Condom or having a partner with a vasectomy with either confirmed azoospermia or performed at least 6 months prior to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments. 2. Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), oestrogens, GnRH-Agonists/Antagonists, hormonal contraceptives, systemic glucocorticoids (oral and injectable), and/or treatments with potent inhibitors or inducers of CYP3A4. Wash-out periods prior to Visit I are as follows: a. Progestins and Oestrogens: 1 month b. GnRH-Agonists/Antagonists: 3 months c. Systemic glucocorticoids: 1 month (3 months after depot injections) d. CYP3A4 inhibitors or inducers: 2 weeks 3. Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study. 4. Subject has a current problem with alcohol or drug abuse. 5. Subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 6. Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject’s safety or interfere with study evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the treatment satisfaction of patients receiving repeated intermittent ulipristal acetate treatment courses using a Global Study Treatment Satisfaction Questionnaire;Secondary Objective: - To assess the treatment satisfaction of pts receiving repeated intermittent ulipristal acetate courses using a Global Study Treatment Satisfaction Questionnaire (at additional time points) - To assess QoL (measured with EQ-5D and UFS-QoL questionnaires) and pain (using VAS) - To assess the sustained efficacy of repeated intermittent 3-month courses of daily adm of ulipristal acetate on myoma size - To assess uterine bleeding characteristics (using PBAC) at re-start of treatment at the beginning of the study in patients who have already completed 4 previous courses of ulipristal acetate - To assess the long-term safety of repeated intermittent 3-month administration of ulipristal acetate, specifically with regards to the endometrium and the occurrence of adverse events - To assess the incidence of PAEC, 10-18 days after the 1st menstruation following the last course with ulipristal acetate - To asses the incidence and type of surgery for uterine myomas during the study period;Primary end point(s): - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit II (Average score of the first 3 questions) - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit III (Average Score of the first 3 questions).;Timepoint(s) of evaluation of this end point: At visit II and visit III | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit I (Average score of the first 3 questions). - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit IV (Average score of the first 3 questions). - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visits I, II, III and IV (Individual component scores). - Change from visit 2 of Pearl III (PGL09-026) and visit F of Pearl III extension (PGL09-027) to visits II, III and IV in quality of life (using EQ-5D and UFS-QoL questionnaires) and in pain (using VAS). - Change from visit 1 of Pearl III (PGL09-026) and visit F of Pearl III extension (PGL09-027) to visits II, III and IV in myoma size, measured on the three largest myomas identified at visit 1 of PGL09-026, by transvaginal ultrasound. - Change from the first menstruation at the start of Pearl III (PGL09-026) study to the first menstrual bleeding at re-start of the first ulipristal acetate treatment course (in PGL11-024) in strength of the bleeding, using the Pictorial Bleeding Assessment Chart (PBAC). Safety: - Number and proportion of subjects experiencing treatment-emergent adverse events including patient-reported adverse events and clinically significant changes in the parameters listed below: o Laboratory parameters (haematology, chemistry, lipids). Change from visit F of Pearl III extension (PGL09-027) to visits II, III and IV in endometrial thickness assessed by transvaginal ultrasound. o Visit III endometrium biopsy (i.e. hyperplasia, adenocarcinoma). Exploratory: - Frequency of PAEC observed in the endometrial biopsy, on day 10-18 after the first menstruation following the last treatment course with ulipristal acetate. - Proportion of subjects having surgery or any invasive procedure for myoma treatment at any time during the study (type of surgery/ procedure performed).;Timepoint( | — |
Countries
Austria, Belgium, Poland, Spain
Contacts
Public ContactGeneral Information Desk
PregLem S.A.
Outcome results
None listed