E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Partial Androgen Deficiency in Aging Males |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the change in lean body mass ater 6 months treatment with Tesotgel (50mg to 75mg testosterone/day) compated to placebo. |
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E.2.2 | Secondary objectives of the trial |
• To assess the change in lean body mass during open label treatment with Testogel® from study month 6 to 18. (During this period patients randomized to Testogel® will undergo their 6th to 18th month of treatment, patients randomized to placebo will start treatment with Testogel® and undergo up to 12 months of active treatment).
• To assess the change in lean body mass, measured by DEXA within 3 subgroups defined by total testosterone measured at the central laboratory at the screening visit: • <10nmol/l (<2.9ng/ml) • 10 to <12nmol/l (2.9 to <3.5ng/ml) • 12 to <15nmol/l (3.5 to <4.3ng/ml) • To assess the change in total body mass, fat mass and bone density, measured by DEXA • Evaluation of symptoms by the aging males’ symptoms (AMS) rating scale • Change in testosterone (central laboratory)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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
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E.4 | Principal exclusion criteria |
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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Patients who have received 6 months of treatment in the study will be assessed to see the change in lean body mass as measured by DEXA / dual-energy x-ray absorptiometry. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial is the last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |