Trials / Completed
CompletedNCT00740831
PGL4001 Versus GnRH-agonist in Uterine Myomas
A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- PregLem SA · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PGL4001 | tablets |
| DRUG | leuprorelin | solution for injection |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2010-01-01
- Completion
- 2010-06-01
- First posted
- 2008-08-25
- Last updated
- 2012-12-17
- Results posted
- 2012-11-16
Locations
46 sites across 9 countries: Austria, Belgium, France, Germany, Israel, Italy, Netherlands, Poland, Spain
Source: ClinicalTrials.gov record NCT00740831. Inclusion in this directory is not an endorsement.