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Testogel · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Testogel (Testosterone, BAYV001915) | DRUG | 50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months |
| Placebo | DRUG | 5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1 |
Inclusion Criteria: * Symptomatic hypogonadism * Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study Exclusion Criteria: * Patients with any contraindication for testosterone use
Testogel is a testosterone therapy developed for androgen deficiency. It is being studied in men with partial androgen deficiency of aging males, a condition linked to low testosterone levels. The Phase 3 trial enrolled men aged 50 and older across eight European countries.
Testogel is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 3 clinical trial evaluating the therapy in men with partial androgen deficiency of aging males.
Testogel is in Phase 3 clinical development. The completed Phase 3 trial, NCT00185198, evaluated its efficacy and safety in men with partial androgen deficiency of aging males. It is an investigational therapy and has not been approved by the FDA for this indication.
Testogel has been studied in one Phase 3 trial, NCT00185198, titled Efficacy and Safety of Testogel in Men With Partial Androgen Deficiency of Aging Males. The trial is completed, enrolled 363 participants, and was conducted in Austria, Finland, Germany, Ireland, Italy, Spain, Sweden, and the United Kingdom.
Yes, Testogel is a testosterone-based therapy, also known as testosterone or by the code BAYV001915. It is a small molecule formulation developed by Bayer AG for androgen deficiency in aging men.