A Phase III, multicentre, clinical study investigating the efficacy and safety of 3-months open-label treatment with PGL4001, followed by a randomised, double-blind placebo controlled period of 10 days treatment with progestin, in subjects with myomas and heavy uterine bleeding. - PEARL III: PGL4001 Efficacy Assessment in Reduction of symptoms due to uterine Leiomyomata
- Conditions
- terine 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: 12.1Level: LLTClassification code 10046801Term: Uterine myoma
- Registration Number
- EUCTR2010-018999-25-BE
- Lead Sponsor
- PregLem S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
To be eligible for inclusion into this study, the subjects must fulfil all of the following criteria:
1.Provision of written informed consent prior to any study related procedures.
2.Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
3.Subject with a Body Mass Index =18 and =40.
4.Subject with hormonal levels FSH = 20 mIU/mL at screening.
5.Subject with regular menstrual cycles =22 and =35 days.
6.Subject with myomatous uterus size < 16 weeks.
7.Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
8.Subject complained of strong uterine bleeding (subjective assessment).
9.Subject is eligible for hysterectomy or myomectomy.
10.Subject has no significant findings at clinical breast examination at the screening visit.
11.Females of childbearing potential have to practice a non-hormonal method of contraception until completion of visit 7 among one of the following:
-Sexual abstinence
-Diaphragms
-Condom or partner with a vasectomy with confirmed azoospermia or performed at least 6 months prior to the study.
12.Females of non childbearing potential, defined as women with tubal ligation sterilisation at least two months before the screening visit (visit 1)
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
1.Subject has a history of uterus surgery that would interfere with the study, including endometrial ablation or uterine artery embolization.
2.Subject has a history of or current uterus, cervix, ovarian or breast cancer.
3.Subject has a significant finding on Papanikolaou test (PAP) smear within the past 12 months.
4.Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
5.Subject has a large uterine polyp (> 2cm).
6.Subject has calcified myomas and/or calcified uterus.
7.Subject has a known severe coagulation disorder.
8.Subject has one or more ovarian cysts = 4cm diagnosed by ultrasound.
9.Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
10.Subject has been taking:
-Treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within one month before the screening visit.
-Acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid: within one week before the screening visit,
-Treatments with an PRM or progesterone antagonist within one month before the screening visit
-Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one or three months before the screening visit, respectively.
-GnRH agonist within 3 months before the screening visit.
-Treatments which contain PgP substrate (digoxin, fexofenadine), two weeks prior to visit 2.
-Treatments which contain moderate or potent inhibitors or inducers of CYP3A4, two weeks prior to visit 2.
11.Subject 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), hormonal contraceptives, systemic glucocorticoids (oral and injectable), GnRH-Agonists, acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid, treatments which contain PgP substrate (digoxin, fexofenadine), treatments which contain moderate or potent inhibitors or inducers of CYP3A4.
12.Subject has abnormal hepatic function at study entry (defined as aspartate transaminase [AST], alanine transaminase [ALT], gamma glutamyl transferase [GGT], hepatic alkaline phosphatase, or total bilirubin above twice the upper limit of normal). In case of an isolated increase of GGT, the subject may be enrolled if the re-test is within the allowed limits.
13.Subject has lactose or galactose intolerance (i.e. lapp lactase deficiency or glucose-galactose malabsorption).
14.Subject is at high risk of thromboembolic disease. This precaution is necessary because subjects may be randomised to norethisterone acetate.
15.Subject has a positive pregnancy test at baseline, is nursing or planning a pregnancy during the course of the study.
16.Subject has a current (within twelve months prior to screening visit) problem with alcohol or drug abuse.
17.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.
18.Subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safe
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method