EUCTR2005-000852-34-GBActive, not recruitingPhase 1
Double-blind, placebo controlled randomized study of the effects of co-administering testosterone with PDE V inhibitor in ED patients non responders to PDE V inhibitors alone. - TADTEST
SELARL du Dr Jacques BUVAT0 sites430 target enrollmentStarted: October 3, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 430
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •-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 < 4 ng/ml and/or BT < 1 ng/ml) according to a first assay done prior to Visit 1 and a confirmation by a second assay at central laboratory Biolille on blood sampled at Visit 1
- •6.Agrees to make at least 4 attempts at sexual intercourse on 4 separate days during the 4 weeks run-in period with daily Tadalafil 10 mg
- •7.At least 50% of attempts during this period must be unsuccessful according an answer No” at one of the questions 1 (were you able to achieve at least some erection (some enlargement of the penis)?”), 2 (were you able to insert your penis in your partner’s vagina?”) or 3 (did your erection last long enough for you to have successful intercourse?”).
- •8.At the end of the run in phase with Tadalafil 10 mg daily, the patient should provide:
- •-a score of 2, 3 or 4 at Question n°3 of the IIEF
- •-a score of 2, 3 at Question n°4 of the IIEF
- •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
- •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 ml/mn, or serum creatinine > 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 < 90 mm Hg or diastolic blood pressure > 110 or < 50 mm Hg at screening;
- •12.Cardiac disease contra-indicating any sexual activity;
- •13.Unstable angina within 6 months before Visit 1;
- •14.Angina during sexual intercourse within 6 months before Visit 1;
- •15.Myocardial Infarction within 90 days before Visit 1;
- •16.Coronary artery by-pass graft surgery or percutaneous coronary intervention (angioplasty or stent insert) within 90 days before Visit 1;
- •17.Severe cardiac rhythm disturbances e.g. supraventricular arrhythmia with a ventricular response >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;
Investigators
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