Abstract: PD69-06
Sources of Funding: Support from Trimel/Acerus Pharmaceuticals for the Phase 3 clinical trial.

Introduction

Male hypogonadism is a clinical syndrome resulting from failure of the testis to produce physiologic levels of testosterone (T) due to disruption of the hypothalamic-pituitary-gonadal axis. Hypogonadism is characterized by many ill-effects including mood disturbances, reduced energy levels, and impaired sexual function. A Phase 3 study investigated the safety and efficacy of a 4.5% testosterone gel administered intranasally (nasal testosterone gel - NTG). Herein we describe the efficacy of NTG administration outcomes on erectile function and mood correlations using validated questionnaires.

Methods

The study was a 90-day, randomized, open-label, dose-ranging study in hypogonadal men with sequential safety extensions out to 1 year. 4.5% NTG (125 uL/nostril, 11.0mg testosterone/dose) was self-administered using a multiple-dose dispenser either twice daily (BID) or 3 times a day (TID) for a total dose of 22.0mg or 33.0mg, respectively. Titration was performed based on blood levels so as to achieve the eugonadal range (300 -1050 ng/dL). Erectile function and mood were assessed at baseline (day 0), 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.

Results

Treatment with NTG led to statistically significant improvements in each of the 5 domains of erectile function (F(3,813) = 83.96 p < .001). Most of the benefit was evident by Day 30 (t = -9.8714, df = 288, p-value < .001) with much smaller increases until study completion (Figure 1). Similar to erectile function, NTG produced clinically and statistically significant improvements in mood (PANAS) by Day 30, with continued (non-significant) improvements seen through study completion (Figure 2).

Conclusions

NTG achieves large, clinical improvements in erectile function and mood within 30 days of treatment, with the added bonus of improvements in sexual desire. NTG is a safe, effective, and unique form of TTh, and is approved for use in the United States.

Funding

Support from Trimel/Acerus Pharmaceuticals for the Phase 3 clinical trial.