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Testosterone 2% · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| Testosterone Solution 2% | DRUG | Administered topically |
| Placebo Solution | DRUG | Administered topically |
Inclusion Criteria: * Total testosterone level \<10.4 nanomoles per liter (nmol/L) \[300 nanograms per deciliter (ng/dL)\] at screening * Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction: delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ...
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.