Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).

NCT03242590 ↗

Phase 3 Completed 95 enrolled Lipocine Inc.

NaSingle-groupOpen-labelTreatment

Summary

Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.

Timeline

Start: 2016-12
Primary completion: 2017-03
Completion: 2017-07

Outcome

Met primary endpoint

release “TLANDO successfully met the FDA primary efficacy guidelines in the DV study” lipocine.com ↗

release “As previously disclosed, the DV study met its primary endpoint, with TLANDO restoring testosterone levels to the normal range in hypogonadal males.” lipocine.com ↗

Publications

DelConte A, Papangkorn K, Kim K, Bruno BJ, Chidambaram N, Khera M, Goldstein I, Kohler TS, Miner M, Dobs AS, Patel MV. A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism. Andrology. 2022 May;10(4):669-676. doi: 10.1111/andr.13153. Epub 2022 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Testosterone Undecanoate	Small molecule	225 mg	Oral