Lipocine Inc. Announces First Patient Dosed In Phase 3 Study For Oral Testosterone Replacement Therapy
Published: Feb 10, 2014
SALT LAKE CITY, Feb. 10, 2014 (GLOBE NEWSWIRE) -- Lipocine Inc. (OTCQB:LPCN), a specialty pharmaceutical company, today announced that the first patient has been dosed in 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, an oral testosterone replacement therapy, in hypogonadal men with low testosterone (Low T; www.lowtstudy.com). Approximately 300 patients are expected to be enrolled in multiple sites in the United States. The company expects to report top-line efficacy data for the trial in the second half 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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