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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

NCT01629563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2019-09-04

Study results available
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Summary

Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

Conditions

  • Uterine Fibroids

Interventions

DRUG

PGL4001 5 mg

PGL4001 5 mg daily administration

DRUG

PGL4001 10 mg

PGL4001 10mg daily administration

Sponsors & Collaborators

  • PregLem SA

    lead INDUSTRY

Principal Investigators

  • Pablo Arrigada, MD · PregLem SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Romania
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629563 on ClinicalTrials.gov