EFFICACY EVALUATION OF TADALAFIL 20 MG ON DEMAND VS TADALAFIL 5 MG DAILY AS TREATMENT MODALITY FOR ERECTILE DYSFUNCTION FOLLOWING RADICAL RADIOTHERAPY IN PROSTATIC CANCER - ND
- Conditions
- Erectile dysfunction following radiotherapy for prostatic cancerMedDRA version: 6.1Level: PTClassification code 10060862
- Registration Number
- EUCTR2007-002058-41-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- normal erectile function before radiotherapy (IIEF score > 25)
- Radiotherapy completed 6 months before
- erectile dysfunction lasting more than 3 months
- no previous LHRH analogues
- patients in a stable relationship
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- patients on hormone treatment
- previous radical prostatectomy
- patients taking nitrates
- patients with diabetes or other diseases potentially inducing neurogenic erectile dysfunction
patients with hypogonadism (total testosterone < 2 ng/ml)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method