Trials / Completed
CompletedNCT01078545
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 729 (actual)
- Sponsor
- Abbott · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.
Detailed description
The remaining target is: \- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine) | Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine. |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2010-03-02
- Last updated
- 2012-01-16
- Results posted
- 2012-01-06
Locations
143 sites across 2 countries: Poland, Ukraine
Source: ClinicalTrials.gov record NCT01078545. Inclusion in this directory is not an endorsement.