MP79-03 COMPARISON OF HEMATOCRIT CHANGE IN TESTOSTERONE-DEFICIENT MEN TREATED WITH INTRANASAL TESTOSTERONE GEL VERSUS INTRAMUSCULAR TESTOSTERONE CYPIONATE: A SINGLE-CENTER RANDOMIZED CLINICAL TRIAL
Bibliographic record
Abstract
You have accessJournal of UrologyCME1 Apr 2023MP79-03 COMPARISON OF HEMATOCRIT CHANGE IN TESTOSTERONE-DEFICIENT MEN TREATED WITH INTRANASAL TESTOSTERONE GEL VERSUS INTRAMUSCULAR TESTOSTERONE CYPIONATE: A SINGLE-CENTER RANDOMIZED CLINICAL TRIAL Marco-Jose Rivero, Jesse Ory, Halifax Canada, Parris Diaz, Raul Clavijo, Nannan Thirumavalavan, Ruben Blachman-Braun, Justin Loloi, Ari Bernstein, and Ranjith Ramasamy Marco-Jose RiveroMarco-Jose Rivero More articles by this author , Jesse OryJesse Ory More articles by this author , Halifax CanadaHalifax Canada More articles by this author , Parris DiazParris Diaz More articles by this author , Raul ClavijoRaul Clavijo More articles by this author , Nannan ThirumavalavanNannan Thirumavalavan More articles by this author , Ruben Blachman-BraunRuben Blachman-Braun More articles by this author , Justin LoloiJustin Loloi More articles by this author , Ari BernsteinAri Bernstein More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone therapy is associated with rise in hematocrit (HCT) and subsequent risk of polycythemia and thrombotic events. Incidence of these side effects may vary depending on the route of administration of testosterone therapy formulation. In this study, we compared the effects of intranasal testosterone gel (NT) and intramuscular testosterone cypionate (TC) on HCT and serum total testosterone (T) levels in testosterone-deficient men over 4 months. METHODS: Patients between 18 and 75 years of age with a diagnosis of testosterone deficiency were recruited. Testosterone deficiency (TD) was defined as two measurements of serum total testosterone below 300 ng/dL combined with one or more characteristic clinical symptoms. Men were randomized (1:1) to receive either NT (5.5 mg per nostril) three times a day or TC (200 mg intramuscularly) once every two weeks. The primary outcomes were changes in HCT and serum T before and after 4 months of treatment. Secondary outcomes were changes in estradiol, prostate-specific antigen, and 17-hydroxyprogesterone. RESULTS: 49 men were randomized to receive either NT (n=20) or TC (n=29). The median participant age was 47 years with a mean serum T of 236.6 ng/dL and mean HCT of 43.3%. The prevalence of participants who screened positive for obstructive sleep apnea on STOP-BANG questionnaire was 70% for the NT group and 72% for the TC group. Men in both groups experienced significantly increased serum T levels throughout the study period (p<0.001), although a larger increase was seen in the TC group. There was an increase in the mean HCT of the TC group from 42.6% to 46.0% at 4-month follow-up (p=0.006), while the NT group experienced no significant changes in mean HCT (p=0.903). The TC group experienced significant increases in estradiol (p<0.001) and decreases in 17-hydroxyprogesterone (p<0.001) at 4-month follow-up, while the NT group experienced no such changes. CONCLUSIONS: Although both NT and TC regimens are effective in treating men with TD, NT does not appear to significantly affect HCT levels. Patients who are at increased risk of developing polycythemia or those who wish to avoid changes in estradiol or 17-hydroxyprogesterone levels may benefit from short-acting testosterone therapy formulations such as NT. Source of Funding: This project was funded by an investigator-initiated grant provided by Acerus Pharmaceuticals © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1142 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Marco-Jose Rivero More articles by this author Jesse Ory More articles by this author Halifax Canada More articles by this author Parris Diaz More articles by this author Raul Clavijo More articles by this author Nannan Thirumavalavan More articles by this author Ruben Blachman-Braun More articles by this author Justin Loloi More articles by this author Ari Bernstein More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF downloadLoading ...
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.017 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".