Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone · 1 trial · 1 indication
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 2% testosterone gel |
| Name | Type | Description |
|---|---|---|
| Testosterone | DRUG | 2% gel |
Inclusion Criteria: * Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by: * Single serum total testosterone concentration \< 250 ng/dL, or * Two consecutive serum total testosterone concentrations \< 300 ng/dL (determined at least one week apart during the screening ...
Testosterone is used for the treatment of hypogonadism and male hypogonadism, conditions in which the body does not produce enough testosterone. It is being developed as a topical gel formulation for men aged 18 years and older.
Testosterone is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in Phase 3 clinical development for the treatment of hypogonadism in men.
Testosterone is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and efficacy for treating hypogonadism.
Testosterone has been studied in two completed Phase 3 trials. NCT00522431 enrolled 149 males with hypogonadism, and NCT01228071 enrolled 34 males with male hypogonadism in the United States. Both trials were uncontrolled and not randomized or double-blinded.
Testosterone is a small molecule that works by supplementing or replacing endogenous testosterone in men with hypogonadism. It is administered as a topical gel to restore testosterone levels to a normal range, addressing symptoms associated with low testosterone.