Abstract
To evaluate the effect of short-acting 4.5% nasal testosterone gel (Natesto) on serum testosterone, gonadotropins, total motile sperm count (TMSC), health-related quality of life, and sexual function.
Single-institution, open-label, single-arm trial, conducted between November 2017 and September 2019 at the University of Miami. Men aged 18-55 diagnosed with symptomatic hypogonadism (total testosterone < 300ng/dL on 2 occasions) were included. Men with azoospermia, vasectomy or a TMSC < 5 million were excluded. Enrolled patients were treated with Natesto, a short-acting nasal testosterone (125 uL/nostril, 11.0 mg T/dose, TID) for 6 months.
In total, 60 men were enrolled in the study. Of these, 44 and 33 patients were evaluated for Testosterone (T) at 3 and 6 months, respectively. A total of 31 patients (93.9%) reached a normal T level (>300ng/dL) at 6 months. Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels were maintained within the normal range in 81.8% and 72.7% of patients at 6 months, respectively. Total motile sperm count was maintained with TMSC >5 million over the treatment period in 88.4% of men at 3 months and 93.9% at 6 months. There were statistically significant improvements on International Index of Erectile Function (IIEF) sexual desire and overall satisfaction domains at 6 months.
Natesto appears to increase testosterone while maintaining semen parameters in a majority of men. Natesto has the potential to be a safe and effective treatment for men with functional hypogonadism who wish to preserve semen parameters. Long-term studies beyond 6 months are needed before we can safely prescribe nasal testosterone gel for men interested in fertility.
