Cargando…

Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials

PURPOSE: Testosterone replacement therapy (TRT) can potentially cause decreased spermatogenesis and subsequent infertility. Recent studies have suggested that 17-hydroxyprogesterone (17-OHP) is a reliable surrogate for intratesticular testosterone (ITT) that is essential for spermatogenesis. We eval...

Descripción completa

Detalles Bibliográficos
Autores principales: Diaz, Parris, Reddy, Rohit, Blachman-Braun, Ruben, Zucker, Isaac, Dullea, Alexandra, Gonzalez, Daniel C., Kresch, Eliyahu, Ramasamy, Ranjith
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Society for Sexual Medicine and Andrology 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10042650/
https://www.ncbi.nlm.nih.gov/pubmed/35791295
http://dx.doi.org/10.5534/wjmh.210261
_version_ 1784912975096709120
author Diaz, Parris
Reddy, Rohit
Blachman-Braun, Ruben
Zucker, Isaac
Dullea, Alexandra
Gonzalez, Daniel C.
Kresch, Eliyahu
Ramasamy, Ranjith
author_facet Diaz, Parris
Reddy, Rohit
Blachman-Braun, Ruben
Zucker, Isaac
Dullea, Alexandra
Gonzalez, Daniel C.
Kresch, Eliyahu
Ramasamy, Ranjith
author_sort Diaz, Parris
collection PubMed
description PURPOSE: Testosterone replacement therapy (TRT) can potentially cause decreased spermatogenesis and subsequent infertility. Recent studies have suggested that 17-hydroxyprogesterone (17-OHP) is a reliable surrogate for intratesticular testosterone (ITT) that is essential for spermatogenesis. We evaluated data from two ongoing open-label, randomized, two-arm clinical trials amongst different treatment preparations (Trial I) subcutaneous testosterone pellets (TP) and (Trial II) intranasal testosterone (NT) or intramuscular testosterone cypionate (TC). MATERIALS AND METHODS: Seventy-five symptomatic hypogonadal men (2 serum testosterone <300 ng/dL) were randomized into open label randomized clinical trials. Eligible subjects received 800 mg TP, 11 mg TID NT or 200 mg ×2 weeks TC. 17-OHP and Serum testosterone were evaluated at baseline and follow-up. The primary outcome was changes in 17-OHP. Secondary outcome was changes in serum testosterone. Data was analyzed by two-sample and single-sample t-tests, and determination of equal or unequal variances was computed using F-tests. RESULTS: Median participant age was 45 years old, with overall baseline 17-OHP of 46 and serum testosterone of 223.5 ng/dL. 17-OHP significantly decreased in subjects prescribed long-acting TP or TC. The 4-month change in 17-OHP in the NT group (-33.3% from baseline) was less than the change seen in TC (-65.3% from baseline) or TP (-44% from baseline) (p=0.005). All testosterone formulations increased serum testosterone levels at follow-up, with the largest increase seen in TC (+157.6%), followed by NT (+114.3%) and TP (+79.6%) (p=0.005). CONCLUSIONS: Short-acting nasal testosterone appear to have no impact on serum 17-OHP especially in comparison to long-acting testosterone formulations. All modalities saw significant increases in serum testosterone levels at follow-up. NT and other short acting testosterone formulations may better preserve ITT and be beneficial for hypogonadal men seeking to maintain fertility potential while on TRT.
format Online
Article
Text
id pubmed-10042650
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Korean Society for Sexual Medicine and Andrology
record_format MEDLINE/PubMed
spelling pubmed-100426502023-04-01 Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials Diaz, Parris Reddy, Rohit Blachman-Braun, Ruben Zucker, Isaac Dullea, Alexandra Gonzalez, Daniel C. Kresch, Eliyahu Ramasamy, Ranjith World J Mens Health Original Article PURPOSE: Testosterone replacement therapy (TRT) can potentially cause decreased spermatogenesis and subsequent infertility. Recent studies have suggested that 17-hydroxyprogesterone (17-OHP) is a reliable surrogate for intratesticular testosterone (ITT) that is essential for spermatogenesis. We evaluated data from two ongoing open-label, randomized, two-arm clinical trials amongst different treatment preparations (Trial I) subcutaneous testosterone pellets (TP) and (Trial II) intranasal testosterone (NT) or intramuscular testosterone cypionate (TC). MATERIALS AND METHODS: Seventy-five symptomatic hypogonadal men (2 serum testosterone <300 ng/dL) were randomized into open label randomized clinical trials. Eligible subjects received 800 mg TP, 11 mg TID NT or 200 mg ×2 weeks TC. 17-OHP and Serum testosterone were evaluated at baseline and follow-up. The primary outcome was changes in 17-OHP. Secondary outcome was changes in serum testosterone. Data was analyzed by two-sample and single-sample t-tests, and determination of equal or unequal variances was computed using F-tests. RESULTS: Median participant age was 45 years old, with overall baseline 17-OHP of 46 and serum testosterone of 223.5 ng/dL. 17-OHP significantly decreased in subjects prescribed long-acting TP or TC. The 4-month change in 17-OHP in the NT group (-33.3% from baseline) was less than the change seen in TC (-65.3% from baseline) or TP (-44% from baseline) (p=0.005). All testosterone formulations increased serum testosterone levels at follow-up, with the largest increase seen in TC (+157.6%), followed by NT (+114.3%) and TP (+79.6%) (p=0.005). CONCLUSIONS: Short-acting nasal testosterone appear to have no impact on serum 17-OHP especially in comparison to long-acting testosterone formulations. All modalities saw significant increases in serum testosterone levels at follow-up. NT and other short acting testosterone formulations may better preserve ITT and be beneficial for hypogonadal men seeking to maintain fertility potential while on TRT. Korean Society for Sexual Medicine and Andrology 2023-04 2022-04-22 /pmc/articles/PMC10042650/ /pubmed/35791295 http://dx.doi.org/10.5534/wjmh.210261 Text en Copyright © 2023 Korean Society for Sexual Medicine and Andrology https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Diaz, Parris
Reddy, Rohit
Blachman-Braun, Ruben
Zucker, Isaac
Dullea, Alexandra
Gonzalez, Daniel C.
Kresch, Eliyahu
Ramasamy, Ranjith
Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials
title Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials
title_full Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials
title_fullStr Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials
title_full_unstemmed Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials
title_short Comparison of Intratesticular Testosterone between Men Receiving Nasal, Intramuscular, and Subcutaneous Pellet Testosterone Therapy: Evaluation of Data from Two Single-Center Randomized Clinical Trials
title_sort comparison of intratesticular testosterone between men receiving nasal, intramuscular, and subcutaneous pellet testosterone therapy: evaluation of data from two single-center randomized clinical trials
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10042650/
https://www.ncbi.nlm.nih.gov/pubmed/35791295
http://dx.doi.org/10.5534/wjmh.210261
work_keys_str_mv AT diazparris comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT reddyrohit comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT blachmanbraunruben comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT zuckerisaac comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT dulleaalexandra comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT gonzalezdanielc comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT krescheliyahu comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials
AT ramasamyranjith comparisonofintratesticulartestosteronebetweenmenreceivingnasalintramuscularandsubcutaneouspellettestosteronetherapyevaluationofdatafromtwosinglecenterrandomizedclinicaltrials