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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

2014-08-27 03:12:25 | BioPortfolio

Summary

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

Description

PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Uterine Fibroids

Intervention

PGL4001, placebo, PGL4001, progestin

Location

Cliniques Universitaires Saint-Luc
Bruxelles
Belgium
1200

Status

Recruiting

Source

PregLem SA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:25-0400

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Medical and Biotech [MESH] Definitions

A synthetic progestin which is useful for the study of progestin distribution and progestin tissue receptors, as it is not bound by transcortin and binds to progesterone receptors with a higher association constant than progesterone.

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Tumors or cancer of the UTERINE CERVIX.

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