MedTrace Logo

PGL4001 Versus GnRH-agonist in Uterine Myomas

NCT00740831 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2012-12-17

Study results available
· View outcomes & findings →

Summary

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Conditions

  • Uterine Myomas

Interventions

DRUG

PGL4001

tablets

DRUG

leuprorelin

solution for injection

Sponsors & Collaborators

  • PregLem SA

    lead INDUSTRY

Principal Investigators

  • Dr Elke Bestel · PregLem SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-01-31
Completion
2010-06-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT00740831 on ClinicalTrials.gov