Multicenter, double blind, randomized, placebo controlled study of Testogel® (testosterone 50–100mg) to evaluate its efficacy and safety in men presenting with typical symptoms of partial androgen deficiency of aging males (PADAM) over a period of 6 months with 12 months open label follow-up - European Testogel study in PADAM
- Conditions
- Partial Androgen Deficiency in Aging Males
- Registration Number
- EUCTR2004-001545-15-IE
- Lead Sponsor
- Schering AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 0
1.Men aged 50 to 80 inclusive
2.Symptomatic hypogonadism as defined by i and ii:
i.Total testosterone <15nmol/l (<4.3ng/ml), bioavailable testosterone will be calculated9 from total testosterone and sex hormone binding globulin and must be <4.43nmol/l (<1.28ng/ml)
ii.Aging males’ symptom score >36
3.Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
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
1.Use of androgen therapy or anabolic steroids within 12 months of entry into the study (i.e. screening visit/visit 1)
2.Contraindication to treatment with Testogel® according to the SPC
3.Hypersensitivity to the active substances or any of the excipients of Testogel®
4.Extensive skin abnormalities that could affect absorption of the gel
5.Diagnosed sleep apnea
6.Polycythemia
7.Hematocrit >50% at entry to the study (i.e. screening visit/visit 1)
8.Prolactin >25ng/ml
9.Organic hypothalamic-pituitary pathology
10.Severe psychiatric disease
11.Prostate specific antigen (PSA) =4ng/ml
12.Severe symptomatic benign prostatic hyperplasia (IPSS sum score =20)
13.Concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone
14.Body mass index >35kg/m2
15.Uncontrolled thyroid disorders
16.Diabetes mellitus with vascular changes, or which is uncontrolled
17.Epilepsy not adequately controlled by treatment
18.Patients requiring fertility treatment
19.Any clinically significant chronic disease that might, in the opinion of the investigator, compromise patient’s safety interfere with the evaluations, or preclude completion of the trial (e.g. hemochromatosis, chronic lung disease, chronic malabsorption disease)
20.History of alcohol or drug abuse
21.Medical, psychiatric or other conditions that compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
22.Hypertension which is not adequately controlled on therapy
23.Severe cardiac, hepatic or renal insufficiency
24.Suspicion of, current, or past history of prostate or breast cancer
25.Metal implants in the body (metal implants in the head will not exclude patients from participation)
26.Previous randomization into this study
27.Concurrent participation in another clinical trial within 1 month of entry into this study (i.e. screening visit/visit 1) or throughout the duration of the study.
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