Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.
Phase of Trial: Phase I
Latest Information Update: 20 Oct 2017
At a glance
- Drugs Testosterone undecanoate (Primary)
- Indications Hypogonadism
- Focus Pharmacokinetics; Registrational
- Acronyms DF
- Sponsors Lipocine
- 09 Aug 2017 According to a Lipocine media release, based on the data from dosing validation study (see profile 280522) and integrated safety set (ISS) from all previously conducted clinical trials including SOAR study (see profile 225746), the company has resubmitted a New Drug Application (NDA) for LPCN 1021 for testosterone replacement therapy (TRT) in adult males for hypogonadism. Six-month review by the FDA and PDUFA date expected in the first quarter of 2018.
- 03 Aug 2017 Status changed from active, no longer recruiting to completed.
- 19 Jun 2017 Results from this trial published in a Lipocine Media Release.