Nelson Vergel
Founder, ExcelMale.com
This product is already approved in Canada and other countries. It is a safe oral testosterone undecanoate but it has a short life, so it has to be taken 3 times a day. I am not sure who would be willing to take a pill that frequently when we now have some many options that can be taken once a day (gels), once a week (T enanthate and cypionate), once every two months (T pellets or T undecanoate injections).
Lipocine Inc. a specialty pharmaceutical company, today announced that the Company has completed enrollment of its Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study ( http://clinicaltrials.gov/show/NCT02081300 ). The trial is designed to evaluate the safety and efficacy of LPCN 1021, oral testosterone undecanoate ("TU"), in hypogonadal men with low testosterone ("Low T"). The Company expects top-line efficacy data for the trial to be available in the third quarter of 2014, with a New Drug Application ("NDA") filing with the U.S. FDA anticipated in the second half of 2015.
Lipocine Inc. a specialty pharmaceutical company, today announced that the Company has completed enrollment of its Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study ( http://clinicaltrials.gov/show/NCT02081300 ). The trial is designed to evaluate the safety and efficacy of LPCN 1021, oral testosterone undecanoate ("TU"), in hypogonadal men with low testosterone ("Low T"). The Company expects top-line efficacy data for the trial to be available in the third quarter of 2014, with a New Drug Application ("NDA") filing with the U.S. FDA anticipated in the second half of 2015.
