A Phase III, multicentre, clinical study investigating the efficacy and safety of three successive periods of 3-month open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and a drug-free period until return of menses, in subjects with myomas and heavy uterine bleeding. - PEARL III extension

PregLem S.A.0 sites200 target enrollmentAugust 16, 2010

Conditionsterine 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: 14.0Level: 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]

DrugsPrimolut-Nor® 10mg

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: PregLem S.A.
Enrollment: 200
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 16, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

PregLem S.A.

Eligibility Criteria

Inclusion Criteria

•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 PGL09\-027 study related procedures.
•2\. Subject completed visit 6 of PGL09\-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.
•3\. Subject has no contraindication to enter the extension study, based on the responsible investigator’s judgment.
•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 200
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
•1\. Subject has a large uterine polyp (\> 2cm).
•2\. Subject has one or more ovarian cysts \= 4cm diagnosed by ultrasound at visit 6 of PGL09\-026\.
•3\. 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), acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins, antifibrynolytic drugs such as tranexamic acid, treatments containing PgP substrates (digoxin, fexofenadine), and/or treatments containing moderate or potent inhibitors or inducers of CYP3A4\.
•4\. Subject has abnormal hepatic function at re\-test (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). A re\-test will be performed if hepatic function test values are above twice the upper limit of normal at visit 5 of PGL09\-026 study. If the second test result is still above twice the upper limit of normal, the subject cannot be included. In case of isolated GGT, the subject may be enrolled if the re\-test is within the allowed limits.
•5\. Subject has a lactose or galactose intolerance (i.e. lapp lactase deficiency or glucose\-galactose malabsorption)
•6\. Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
•7\. Subject has a current problem with alcohol or drug abuse.
•8\. 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.
•9\. Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or interfere with study evaluations.