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testosterone undecanoate, LPCN 1021 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Oral testosterone undecanoate, LPCN 1021 | EXPERIMENTAL | Oral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7. |
| Topical testosterone gel 1.62 % | OTHER | Topical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28 |
| Name | Type | Description |
|---|---|---|
| Oral testosterone undecanoate, LPCN 1021 | DRUG | - |
| Topical testosterone gel 1.62 % | DRUG | - |
Inclusion Criteria: 1. Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). 2. Serum total testosterone \< 300 ng/dL based on 2 consecutive blood samples Exclusion Criteria: A subject will not be eligible for study partic...
Testosterone undecanoate, LPCN 1021 is an investigational oral small molecule being developed for the treatment of male hypogonadism, a condition characterized by low testosterone levels in men. It is currently in Phase 3 clinical development.
Testosterone undecanoate, LPCN 1021 is being developed by Lipocine Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LPCN. The company is advancing this oral testosterone replacement therapy for men with hypogonadism.
Testosterone undecanoate, LPCN 1021 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial for this oral testosterone replacement therapy has been completed.
Testosterone undecanoate, LPCN 1021 has one completed Phase 3 clinical trial, identified as NCT02081300. This randomized, controlled study evaluated the safety and efficacy of oral LPCN 1021 in 315 men with low testosterone or hypogonadism, with participants aged 18 years and older.
Yes, testosterone undecanoate, LPCN 1021 is the same drug as LPCN 1021. The compound is an oral formulation of testosterone undecanoate, and LPCN 1021 is the development code used by Lipocine Inc. for this investigational therapy for male hypogonadism.