Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone · 2 trials · 2 indications
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
The AUC from time 0 to 72 hours \[AUC (0-72)\] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
| Arm | Type | Description |
|---|---|---|
| Placebo Solution | PLACEBO_COMPARATOR | Placebo Solution applied topically once daily for 12 weeks. |
| Testosterone Solution | EXPERIMENTAL | Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks. |
| Testosterone Unshaved | EXPERIMENTAL | No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods. |
| Testosterone Unshaved + Deodorant Spray | EXPERIMENTAL | Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
| Testosterone Unshaved + Deodorant Antiperspirant Spray | EXPERIMENTAL | Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
| Testosterone Unshaved + Deodorant Antiperspirant Stick | EXPERIMENTAL | Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
| Testosterone Shaved | EXPERIMENTAL | No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods. |
| Testosterone Shaved + Deodorant Antiperspirant Spray | EXPERIMENTAL | Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. |
| Name | Type | Description |
|---|---|---|
| Testosterone Solution | DRUG | Administered topically to axillae. |
| Placebo Solution | DRUG | Administered topically to axillae. |
| Testosterone | DRUG | Administered topically to axillae |
| Deodorant Spray | OTHER | Administered topically to axillae |
| Deodorant and Antiperspirant Combination Spray | OTHER | Administered topically to axillae |
| Deodorant and Antiperspirant Combination Stick | OTHER | Administered topically to axillae |
Inclusion Criteria: * Total testosterone level \<300 nanogram per deciliter (ng/dL) \[10.4 nanomole per Liter (nmol/L)\] at each of 2 screening visits * At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive * Prostate Specific Antigen (PSA) \<4...
Testosterone is being studied for use in hypogonadism, ejaculatory dysfunction, and healthy participants. It is an investigational small molecule being developed by Eli Lilly and Company. Clinical trials have evaluated its effects on testosterone levels, sex drive, and energy in men with low testosterone.
Eli Lilly and Company (NYSE: LLY) is developing Testosterone. The company has sponsored clinical trials evaluating the drug in men with hypogonadism and ejaculatory dysfunction, as well as in healthy participants.
Testosterone is in clinical development. While one completed trial was a Phase 2 study, another was a Phase 3 study, and a third was a Phase 1 study. The drug remains investigational and has not been approved by the FDA.
Testosterone has been studied in three completed trials. NCT01419236 was a Phase 2 study in men with ejaculatory dysfunction and hypogonadism. NCT01725451 was a Phase 1 study in healthy participants. NCT01816295 was a Phase 3 study in men with hypogonadism.
Testosterone is the drug name used in clinical trials sponsored by Eli Lilly and Company. The trials evaluate the effects of a testosterone solution on men with low testosterone levels, including measures of sex drive and energy.