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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 430

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 < 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
AND
-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;

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

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