MP36-03 IMPACT OF TESTOSTERONE THERAPY ON INTRATESTICULAR TESTOSTERONE: EVALUATION OF TWO OPEN-LABEL RANDOMIZED CLINICAL TRIALS OF TESTOSTERONE PELLETS, INJECTIONS, AND INTRANASAL GEL IN HYPOGONADAL MEN

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (MP36)1 Sep 2021MP36-03 IMPACT OF TESTOSTERONE THERAPY ON INTRATESTICULAR TESTOSTERONE: EVALUATION OF TWO OPEN-LABEL RANDOMIZED CLINICAL TRIALS OF TESTOSTERONE PELLETS, INJECTIONS, AND INTRANASAL GEL IN HYPOGONADAL MEN Daniel Gonzalez, Eliyahu Kresch, Jesse Ory, Sirpi Nackeeran, Ruben Blachman-Braun, Manuel Molina, and Ranjith Ramasamy Daniel GonzalezDaniel Gonzalez More articles by this author , Eliyahu KreschEliyahu Kresch More articles by this author , Jesse OryJesse Ory More articles by this author , Sirpi NackeeranSirpi Nackeeran More articles by this author , Ruben Blachman-BraunRuben Blachman-Braun More articles by this author , Manuel MolinaManuel Molina More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002045.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone replacement therapy (TRT) can potentially cause infertility via suppression of HPG axis. Intratesticular testosterone (ITT) is vital for spermatogenesis and can be reliably evaluated with serum 17-hydroxyprogesterone (17-OHP) as a serum biomarker. We hypothesized that long-acting TRT will have a significant impact on suppressing ITT production as compared to short-acting TRT. We evaluated data from two simultaneous open-label, randomized, two-arm clinical trials amongst different treatment preparations (Trial I) subcutaneous T pellets and (Trial II) Intranasal Testosterone or Intramuscular Testosterone cypionate (TC). METHODS: Hypogonadal men (2 serum T <300 ng/dL by LC-MS/MS) were randomized into open-label randomized clinical trials. Eligible subjects received: 800mg subcutaneous T pellets or 11mg TID Intranasal T or 200mg x 2 weeks TC for 2 months. Serum T and 17-OHP were collected at baseline and follow-up. Data are presented as a post-hoc analysis of the two randomized clinical trials and reported as the mean percent change (SD). Paired sample analysis (baseline versus follow-up) was performed with Student's T-test to determine change within the different preparations. RESULTS: ITT via 17-OHP significantly decrease among men receiving all the different T preparations.(Fig. 1) Of note, longer acting TRT such as pellets and TC demonstrated the greatest % decrease in 17-OHP, -64 +29 ng/dL and -54 + 31 ng/dL, respectively (p<0.05) as compared to nasal T gel. Shorter acting T preparations such as nasal T gel demonstrated a mean % decrease in 17-OHP -38 +26 (p=0.008), but to a lesser extent as pellets. Changes in ITT paralleled with subjective changes in testis size, with men receiving nasal T gel reported maintenance of testis size whereas those with T pellets or TC reported decreased testis size. CONCLUSIONS: Intranasal T and other short acting forms of TRT may help hypogonadal men maintain ITT and testis size that is critical for maintaining spermatogenesis and fertility potential. The differential effects of TRT (based on half-life) on intratesticular T is novel and should be considered during the decision making for hypogonadal men who wish to preserve future fertility. Source of Funding: Investigator Initiated Grants from Acerus Pharmaceuticals, Canada and Empower Pharmacy © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e636-e637 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Gonzalez More articles by this author Eliyahu Kresch More articles by this author Jesse Ory More articles by this author Sirpi Nackeeran More articles by this author Ruben Blachman-Braun More articles by this author Manuel Molina More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement Loading ...