Lipocine announced top-line results from its phase 3 Study of Oral Androgen Replacement (SOAR) clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.
SOAR is a randomized, open-label, parallel-group, active-controlled clinical study of oral testosterone in hypogonadal males with low testosterone (<300 ng/dL). A total of 210 males were randomly assigned to LPCN 1021 and 105 were randomly assigned to the active control, for 52 weeks of treatment.
LPCN 1021 subjects were started at 225 mg testosterone undecanoate twice daily with a standard meal and then dose titrated, if needed, up to 300 mg twice daily or down to 150 mg twice daily based on serum testosterone measured during weeks 3 and 7.
The primary efficacy endpoint of the percentage of subjects with an average 24-hour serum testosterone concentration (Cavg) within the normal range, which is defined as 300 ng/dL to 1140 ng/dL, after 13 weeks of treatment was met.
In the analysis, 88% of the subjects on active treatment achieved testosterone Cavg within the normal range with lower bound CI of 82%.
Lipocine plans to submit a New Drug Application (NDA) for LPCN 1021 to the FDA in the second half of 2015.
For more information visit Lipocine.com.
This article originally appeared on MPR