PGL4001 Efficacy Assessment in Reduction of symptoms dueto 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: 14.1Level: LLTClassification code 10046801Term: Uterine myomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2012-001465-33-BE

Lead Sponsor: PregLem S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 90

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

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.