Co-Administering Testosterone With PDE5 Inhibitors in ED Patients Non Responders to PDE5 Inhibitors Alone
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V
Inhibitor therapy, which is presently considered as the first choice treatment for most ED
patients. Recent reports stated a high prevalence of low serum testosterone levels in such
non responders, and an improvement of their response by combining testosterone therapy with
the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood
testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo
controlled studies have added support to this hypothesis but one involved only 20 patients
while in the other the benefit of combining testosterone was transient. This is a
multi-centric study, double blind placebo controlled and randomized as concerns testosterone
administration, that aims to objectively assess the efficacy of co-administering testosterone
with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED
patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure
inclusion and exclusion criteria completion, including a serum testosterone level < 4 ng/ml
for total testosterone or < 1 ng/ ml for bioavailable testosterone. They will then enter a
four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily,
in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to
enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question
(GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a
12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will
include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment
using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study
visit. Safety assessments will be performed in addition during the last visit (physical
examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel +
Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated
according to suboptimal clinical response of the patient, the dose of study medication will
be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo
gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind
treatment phase.