Erectile dysfunction Classification code 10061461
Conditions
Interventions
Trade Name: ANDROTOPIC 50MG
Product Name: Testosterone gel
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Other descriptive name: ANDROGEL
Concentration unit: g gram(s)
Sponsors
CETPARP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. ED complaint ongoing for over 3 months; 2. Age comprise between 45 and 80 y.o.; 3. Had a stable heterosexual relationship for more than 3 months and anticipates having the same partner for all the study 4. Has not responded adequately to the highest available dosage of Tadalafil or other PDE5 inhibitors (20 mg for Tadalafil and Vardenafil, 100 mg for Sildenafil) taken at least at 4 separate occasions, defined as: - a score of 2,3 or 4 at Question n°3 of the IIEF AND - a score of 2 or 3 at Question n°4 of the IIEF; measured prior to Visit 1 5. Low or low-to-normal serum testosterone level (either on total or bioavailable testosterone levels) with respect to the range of men under aged than 50 y.o. (TT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Impotence caused by other primary sexual disorder (e.g. premature ejaculation); 2. History of penile implant or significant penile deformity; 3. Body mass index >35kg/m2; 4. Diabetes mellitus that is uncontrolled (HbA1c level > 10%). HbA1c will be checked at screening for each diabetic patient or suspected to be; 5. Uncontrolled thyroid disorders; 6. Known hyperprolactinemia (serum prolactin > 30ng/ml in local laboratory); 7. Organic hypothalamic-pituitary pathology; 8. History of alcohol, drug or substance abuse within 6 months before Visit 1; 9. Renal insufficiency defined as receiving renal dialysis, having a creatinine clearance 30 mg/ml; 10. Severe hepatic impairment, Child Pugh class C, elevation of AST and/or ALT > 3 x the ULN; 11. Systolic Blood Pressure > 170 or 110 or 100 bpm. at rest despite medical or device therapy, history of refractory spontaneous or induced sustained ventricular tachycardia (heart rate > 100 bpm. for > 30 sec) or fibrillation, automatic internal cardioverter-defibrillator, history of sudden cardiac arrest) within 6 months before Visit 1;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable in the study will be based on the average change from baseline in the Erectile Function Domain Score of the IIEF (question 1-5 +15, possible total score 1 to 30).;Main Objective: The primary objective of this study will be to assess the efficacy of combined therapy with Tadalafil and Testosterone to improve the erectile function of ED patients with low or low normal levels of testosterone that do not respond to Tadalafil alone. For that the administration of testosterone will be randomized, double blind, and placebo controlled while administration of Tadalafil will be performed open labeled. The primary efficacy variable will be the mean change from baseline in the Erectile Function Domain Score of the IIEF (questions 1-5 + 15) on Tadalafil + Testosterone compared to the one on Tadalafil + placebo. ;Secondary Objective: The secondary objectives will be to confirm the beneficial effects of combining testosterone with Tadalafil in the ED patients non-responders to Tadalafil alone by comparing the 2 groups of patients (on Tadalafil + testosterone and on Tadalafil + placebo) as concerns the following parameters at the different times of the study : - rate of “responders” to treatment, defined as the patients having attained a score of 4 or 5 at both Q3 AND Q4 of the IIEF - rate of the patients having achieved a score > 26 at the EFD of the IIEF (considered to define normal erectile function) - mean scores obtained at Questions 3 and 4 of the IIEF - mean scores obtained at the 4 other domains of the IIEF (Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Satisfaction Domains), as well as at the whole IIEF (sum of the 15 questions). - percentage of “YES” responses at questions 2, 3, 4 and 5 of the Sexual Encounter Profile (SEP) | — |
Countries
Austria, Belgium, Finland, Germany, Spain, United Kingdom
Outcome results
None listed