Low Testosterone

December 12, 2016

Aytu BioScience released results of a phase III study of Natesto nasal testosterone gel (NTG) for erectile function and mood in hypogonadal men. The study was a 90-day, randomized, open-label, dose-ranging study in hypogonadal men with sequential safety extensions out to one year. Natesto (125 uL/nostril, 11.0mg testosterone/dose) was self-administered using a multiple-dose dispenser either twice daily (BID) or three times a day (TID) for a total dose of 22.0mg or 33.0mg, respectively. Titration was performed based on blood levels to achieve the eugonadal range (300 -1050 ng/dL). Erectile function and mood were assessed at baseline (day zero), and 30-day intervals through the 90-day treatment period using the International Index of Erectile Function (IIEF) and Positive and Negative Affect Schedule (PANAS), respectively. Treatment with Natesto led to statistically significant improvements in each of the five domains of erectile function (F(3,813)=83.96 p<0.001). Most of the benefit was evident by day 30 (t=-9.8714, df=288, p<0.001). Similar to erectile function, NTG produced clinically and statistically significant improvements in mood (PANAS) by day 30, with continued improvements seen through study completion.

March 9, 2015

Antares Pharma issued results of an ongoing, multi-center, phase III clinical study of enanthate administered once-weekly by subcutaneous injection using the QuickShot auto injector in testosterone deficient adult males. In the study, 150 adult males with hypogonadism (low testosterone) and testosterone blood levels less than 300ng/dL received a starting dose of 75mg of subcutaneously administered testosterone enanthate (QuickShot Testosterone, or QS T) once weekly for six weeks. Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic (PK) profiles were obtained during the 12th week of treatment. The primary endpoint of the population that received one or more doses of QS T was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range. The top-line results are summarized in the table below. Overall, the regimen demonstrated a mean (± standard deviation) steady state concentration of testosterone of 553.3 ± 127.3ng/dL at 12 weeks. The company will be filing an NDA with the FDA and, at the recommendation of the FDA, the company anticipates that it may need approximately 70 additional subjects.

September 29, 2014

Lipocine issued results of a phase III trial of LPCN 1021 for hypogonadal men with low testosterone. The randomized, open-label, parallel-group, active-controlled study of hypogonadal males with low testosterone (< 300ng/dL) enrolled 315 subjects at 40 active sites. 210 were randomized to LPCN 1021 and 105 were randomized to the active control, for 52 weeks of treatment. LPCN 1021 subjects were started at 225mg Testosterone Undecanoate (TU) (equivalent to ~ 142mg of T) twice daily (BID and then dose titrated, if needed, up to 300mg TU BID or down to 150mg TU BID based on serum testosterone measured during weeks three and seven. In the EPS analysis, 88% of the subjects on active treatment achieved testosterone Cavg within the normal range with lower bound CI of 82%. Additionally, sensitivity analysis using the SS reaffirmed the finding that LPCN 1021 successfully met the FDA primary efficacy guideline, as 80% of the subjects on active treatment achieved testosterone Cavg within the normal range with lower bound CI of 74%. Mean Cavg was 447 ng/dL with coefficient of variance of 37%. Lipocine expects to file an NDA with the FDA in the second half of 2015.

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