Lipocine Inc. announced plans to initiate a dosing flexibility (“DF”) study in addition to its previously announced dosing validation (“DV”) study for LPCN 1021. LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The DF study will assess LPCN 1021 in hypogonadal males on a fixed daily dose of 450 mg divided into three equal doses whereas the DV study is assessing the impact of LPCN 1021 in hypogonadal males on a fixed daily dose of 450 mg divided into two equal doses. Lipocine expects resubmission of the LPCN 1021 new drug application (“NDA”) to the U.S. Food and Drug Administration ("FDA") to contain data from both the DV study and the DF study. Lipocine expects the first patient of the DF study to be enrolled in the first quarter of 2017 with top-line results projected in the second quarter of 2017. The DF study is an open-label, fixed dose, single treatment arm study of LPCN 1021 and is expected to enroll 100 hypogonadal males. Efficacy will be assessed via responder analysis at the end of the dosing period which is 24 days. The pre-specified primary endpoint is the percentage of subjects with an average 24-hour serum testosterone concentration (“Cavg”) within the normal range, with secondary endpoints based on maximum serum testosterone concentrations (“Cmax”).