Lipocine Announces Completion of Enrollment in its Oral Testosterone Study

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Nelson Vergel

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 ( ). 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.
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