Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Testosterone Solution 2%, Testosterone 2%, Testosterone Solution, Axiron, LY900011
Testosterone · 3 trials · 3 indications
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed-effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level \[≥200 nanograms per deciliter (ng/dL) versus (vs.) \<200 ng/dL\], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.
This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.
| 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 Solution 2% 60 milligrams (mg) | EXPERIMENTAL | Testosterone Solution 2% 60 mg applied topically once daily with possible 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo solution applied topically once daily for 16 weeks |
| Axiron | EXPERIMENTAL | Axiron administered topically via metered dose pump to each underarm on Day 1 |
| Name | Type | Description |
|---|---|---|
| Testosterone Solution | DRUG | Administered topically to axillae. |
| Placebo Solution | DRUG | Administered topically to axillae. |
| Testosterone Solution 2% | DRUG | Administered topically |
| Axiron | DRUG | Solution administered topically using pump and applicator |
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 hypogonadism, a condition in which men have low testosterone levels, and for ejaculatory dysfunction in men with low testosterone. It is an investigational small molecule developed by Eli Lilly and Company (ticker LLY) and is in Phase 2 clinical development.
Testosterone targets the androgen receptor (AR) and acts as an agonist. By activating this receptor, it is designed to raise testosterone activity in men with low levels. The androgen receptor is the molecular target of the drug, and its agonist activity is the basis of its development for endocrine conditions.
Testosterone is developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly is the sponsor of the clinical studies evaluating the drug in men with low testosterone, including a Phase 3 trial in hypogonadism and a Phase 2 trial in ejaculatory dysfunction.
Testosterone is in Phase 2 development overall, with one completed Phase 2 trial in ejaculatory dysfunction and hypogonadism. A separate Phase 3 trial in hypogonadism has also been completed. The drug is investigational and is not approved for these uses.
Testosterone has been studied in NCT01816295, a completed Phase 3 trial in men with hypogonadism that enrolled 715 participants across the United States, Argentina, Canada, Germany, Italy, Puerto Rico, South Korea, Spain, and the United Kingdom, and in NCT01419236, a completed Phase 2 trial of ejaculatory dysfunction in men with low testosterone that enrolled 76 participants.
Yes. Testosterone is also known as Testosterone Solution 2%, Testosterone 2%, and Testosterone Solution. These names refer to the same Eli Lilly and Company (ticker LLY) investigational product being studied in hypogonadism and ejaculatory dysfunction.