Lipocine Inc. (LPCN) Announces Completion Of Enrollment In Its SOAR Phase 3 Study For Oral Testosterone Replacement Therapy
4/29/2014 9:22:45 AM
SALT LAKE CITY, April 29, 2014 (GLOBE NEWSWIRE) -- Lipocine Inc. (Nasdaq:LPCN), 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. Food and Drug Administration ("FDA") anticipated in the second half of 2015.
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