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Tadalafil for Prevention of Erectile Dysfunction in Prostate Cancer Radiotherapy
NCT00215631Phase 3
Key facts
- Status
- Terminated
- Start
- Oct 2005
- Countries
- 1
- Sponsor
- Erasmus MC
- Modality
- Small Molecules
- Drugs
- tadalafil
- Conditions
- erectile dysfunction (ED)
01
Overview
Phase 3, randomised, double-blind trial in erectile dysfunction (ED) comparing Tadalafil with Placebo (2 arms). Primary endpoint: Maintenance of erectile function defined as a combined score >=8 for IIEF questions 3 and 4 at 12 months. Started Oct 2005; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tadalafil
Tadalafil 20 mg once every two days.
Placebo
Placebo once every two days.
03
Endpoints
Primary
Maintenance of erectile function defined as a combined score >=8 for IIEF questions 3 and 4
Secondary
Erectile function defined as the sum of questions 3 and 4 of the IIEF questionnaire
Erectile function domain of the IIEF and other domains
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