Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
testosterone 2% · 1 trial · 1 indication
The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.
Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.
Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.
| Arm | Type | Description |
|---|---|---|
| 40 mg daily dose of testosterone gel 2% | EXPERIMENTAL | testosterone gel 2% |
| Name | Type | Description |
|---|---|---|
| testosterone gel 2% | DRUG | 40 mg testosterone gel 2% |
Inclusion Criteria: 1. Men aged 18 to 65 years. 2. Have a diagnosis of primary or secondary hypogonadism with a: * Single morning serum total testosterone concentration \<250 ng/dL or * Two (2) consecutive morning serum total testosterone concentrations \<300 ng/dL (determined at least 1 wee...
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.