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Topical testosterone gel 1.62 %
Topical testosterone gel 1.62% works by delivering testosterone through the skin to increase androgen levels in the body.
Topical testosterone gel 1.62% works by delivering testosterone through the skin to increase androgen levels in the body. Used for Treatment of hypogonadism in adult males.
At a glance
| Generic name | Topical testosterone gel 1.62 % |
|---|---|
| Sponsor | Lipocine Inc. |
| Drug class | androgen replacement therapy |
| Target | androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Hormone Replacement Therapy |
| Phase | Phase 3 |
Mechanism of action
This is achieved by the topical application of a gel containing 1.62% testosterone, which is then absorbed through the skin and into the bloodstream, allowing for increased levels of testosterone to be available for the body to use.
Approved indications
- Treatment of hypogonadism in adult males
Common side effects
- Application site reactions
- Gynecomastia
- Acne
Key clinical trials
- Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc (PHASE2)
- Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill (PHASE2)
- Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (PHASE3)
- A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism (PHASE4)
- Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism (PHASE3)
- Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |