Natesto, a short-acting nasal testosterone gel approved for treating hypogonadism in men, increases testosterone levels while maintaining semen parameters in most hypogonadal men, a new study suggests.
“Natesto has the potential to be a safe and effective treatment for men with functional hypogonadism who wish to preserve semen parameters,” Ranjith Ramasamy, MD, of the Miller School of Medicine at the University of Miami, and colleagues concluded in an article published online ahead of print in The Journal of Urology. “Long-term studies beyond 6 months are needed before we can safely prescribe nasal testosterone gel for men interested in fertility.”
Dr Ramasamy’s team conducted a single-institution, open-label, single-arm trial that enrolled 60 men diagnosed with symptomatic hypogonadism (total testosterone less than 300 ng/dL on 2 occasions). The study excluded men with azoospermia, vasectomy, or a total motile sperm count (TMSC) below 5 million. All men were treated with Natesto at a dosage of 125 µL/nostril, 11.0 mg testosterone/dose, 3 times daily for 6 months. Of the 60 men, 44 and 33 were evaluated for testosterone at 3 and 6 months, respectively.
At 6 months, 31 (93.9%) of the 33 patients achieved a normal testosterone level (above 300 ng/dL), and follicle stimulating hormone and luteinizing hormone levels were maintained within the normal range in 81.8% and 72.7% of patients, respectively. TMSC was maintained at over 5 million during the treatment period in 88.4% of men at 3 months and 93.9% at 6 months.
Further, the investigators observed statistically significant improvements in International Index of Erectile Function sexual desire and overall satisfaction domains at 6 months.
Ramasamy R, Masterson TA, Best JC, et al. Effect of Natesto on reproductive hormone, semen parameters and hypogonadal symptoms: A single-center, open-label, single-arm trial [published online April 14, 2020]. J Urol. doi: 10.1097/JU.0000000000001078