Erectile dysfunction following radiotherapy for prostatic cancer MedDRA version: 6.1 Level: PT Classification code 10060862
Conditions
Interventions
Trade Name: CIALIS*4CPR RIV 10MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tadalafil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade N
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether daily low dose tadalafil has better activity than standard dose on demand;Secondary Objective: Tolerability;Primary end point(s): % of responders to tadalafil in each treatment arm according to a positive response to the SEP 2 and SPE 3 question. | — |
Countries
Italy
Outcome results
None listed