Effect of Natesto on Reproductive Hormones, Semen Parameters and Hypogonadal Symptoms: A Single Center, Open Label, Single Arm Trial

Abstract

No AccessJournal of UrologyAdult Urology1 Sep 2020Effect of Natesto on Reproductive Hormones, Semen Parameters and Hypogonadal Symptoms: A Single Center, Open Label, Single Arm TrialThis article is commented on by the following:Editorial CommentEditorial Comment Ranjith Ramasamy, Thomas A. Masterson, Jordan C. Best, Joshua Bitran, Emad Ibrahim, Manuel Molina, Ursula B. Kaiser, Feng Miao, and Isildinha M. Reis Ranjith RamasamyRanjith Ramasamy *Correspondence: Department of Urology, University of Miami, 1120 NW 14th St., #1551, Miami, Florida 33136 E-mail Address: [email protected] Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida , Thomas A. MastersonThomas A. Masterson Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida , Jordan C. BestJordan C. Best Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida , Joshua BitranJoshua Bitran Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida , Emad IbrahimEmad Ibrahim Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida , Manuel MolinaManuel Molina Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida , Ursula B. KaiserUrsula B. Kaiser Division of Endocrinology , Diabetes and Hypertension, Brigham and Woman's Hospital, Harvard Medical School, Boston, Massachusetts , Feng MiaoFeng Miao Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida , and Isildinha M. ReisIsildinha M. Reis Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida Sylvester Biostatistics and Bioinformatics Shared Resource, Miller School of Medicine, University of Miami, Miami, Florida View All Author Informationhttps://doi.org/10.1097/JU.0000000000001078AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: To evaluate the effect of short-acting 4.5% nasal testosterone gel (Natesto) on serum testosterone, gonadotropins, total motile sperm count, health related quality of life and sexual function. Materials and Methods: This was a single institution, open label, single arm trial conducted between November 2017 and September 2019 at the University of Miami. Men 18 to 55 years old diagnosed with symptomatic hypogonadism (total testosterone less than 300 ng/dl on 2 occasions) were included. Men with azoospermia, vasectomy or a total motile sperm count less than 5 million were excluded. Enrolled patients were treated with Natesto, a short-acting nasal testosterone (125 μl per nostril, 11.0 mg testosterone per dose, TID) for 6 months. Results: In total, 60 men were enrolled in the study. Of these, 44 and 33 patients were evaluated for testosterone at 3 and 6 months, respectively. A total of 31 patients (90.9%) reached a normal testosterone level (greater than 300 ng/dl) at 6 months. Follicle stimulating hormone and luteinizing hormone 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 total motile sperm count greater than 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 sexual desire and overall satisfaction domains at 6 months. Conclusions: 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. References 1. : Low testosterone in adolescents & young adults. Front Endocrinol (Lausanne) 2019; 10: 916. Google Scholar 2. : Decline in serum testosterone levels among adolescent and young adult men in the USA. Eur Urol Focus 2020; doi: 10.1016/j.euf.2020.02.006. Crossref, Google Scholar 3. : The application of Clomid in the treatment of male infertility. Mater Med Pol 1985; 17: 131. Google Scholar 4. : Improvements in semen parameters in men treated with clomiphene citrate-A retrospective analysis. Andrologia 2019; 51: e13257. Google Scholar 5. : Clomiphene citrate for the treatment of hypogonadism. 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World Health Organization Task Force on methods for the regulation of male fertility. Lancet 1990; 336: 955. Google Scholar 12. : Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement. BJU Int 2016; 117: 677. Google Scholar 13. : Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies. Can Urol Assoc J 2018; 12: E349. Google Scholar 14. : Testosterone treatment and sexual function in older men with low testosterone levels. J Clin Endocrinol Metab 2016; 101: 3096. Google Scholar 15. : Efficacy and safety of a new topical testosterone replacement gel therapy for the treatment of male hypogonadism. Endocr Pract 2017; 23: 557. Google Scholar Supported by Aytu BioSciences No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology23 Jun 2020Editorial CommentJournal of Urology23 Jun 2020Editorial Comment Volume 204Issue 3September 2020Page: 557-563Supplementary Materials Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordspulsatile flownasal absorptionoligospermiaMetricsAuthor Information Ranjith Ramasamy Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida *Correspondence: Department of Urology, University of Miami, 1120 NW 14th St., #1551, Miami, Florida 33136 E-mail Address: [email protected] Financial interest and/or other relationship with Aytu BioSciences (distributor of Natesto). More articles by this author Thomas A. Masterson Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Jordan C. Best Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Joshua Bitran Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Emad Ibrahim Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Manuel Molina Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Ursula B. Kaiser Division of Endocrinology , Diabetes and Hypertension, Brigham and Woman's Hospital, Harvard Medical School, Boston, Massachusetts Financial interest and/or other relationship with Aytu BioSciences (distributor of Natesto). More articles by this author Feng Miao Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Isildinha M. Reis Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida Sylvester Biostatistics and Bioinformatics Shared Resource, Miller School of Medicine, University of Miami, Miami, Florida More articles by this author Expand All Supported by Aytu BioSciences No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Advertisement PDF downloadLoading ...