MP79-02 PHARMACOKINETICS AND SAFETY OUTCOMES OF COMPOUNDED VERSUS BRANDED TESTOSTERONE PELLETS IN MEN WITH TESTOSTERONE DEFICIENCY: A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED TRIAL
Bibliographic record
Abstract
You have accessJournal of UrologyCME1 Apr 2023MP79-02 PHARMACOKINETICS AND SAFETY OUTCOMES OF COMPOUNDED VERSUS BRANDED TESTOSTERONE PELLETS IN MEN WITH TESTOSTERONE DEFICIENCY: A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED TRIAL Nicholas Deebel, Eliyahu Kresch, Thiago Fernandes Negris Lima, Manuel Molina, Rohit Reddy, Mehul Patel, Justin Loloi, Chase Carto, Daniel Gonzalez, Jesse Ory, Halifax Canada, and Ranjith Ramasamy Nicholas DeebelNicholas Deebel More articles by this author , Eliyahu KreschEliyahu Kresch More articles by this author , Thiago Fernandes Negris LimaThiago Fernandes Negris Lima More articles by this author , Manuel MolinaManuel Molina More articles by this author , Rohit ReddyRohit Reddy More articles by this author , Mehul PatelMehul Patel More articles by this author , Justin LoloiJustin Loloi More articles by this author , Chase CartoChase Carto More articles by this author , Daniel GonzalezDaniel Gonzalez More articles by this author , Jesse OryJesse Ory More articles by this author , Halifax CanadaHalifax Canada More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone deficiency (TD) is a prevalent condition, especially in men ≥45 years old. Treatment of TD with testosterone therapy (TTh) carries numerous metabolic benefits. Subcutaneous Testopel® pellets are FDA approved for the treatment of TD however can impose a significant financial burden to the patient. The objective was to evaluate the safety profile of compounded subcutaneous testosterone pellets and compare the pharmacokinetics between compounded and FDA approved testosterone pellets (Testopel®) for TTh. METHODS: This was a prospective, randomized, non-inferiority clinical trial. We enrolled 75 men diagnosed with TD and randomized them 1:1 ratio to Testopel® and a 100mg compounded pellet group from Empower Pharmaceuticals, an FDA-registered-facility. The patients were implanted with their respective treatment: Testopel® (10 pellets of 75mg) or compounded testosterone pellets (8 pellets of 100mg). Patients were monitored for adverse events with morning laboratory assessment (serum Testosterone, estradiol, 17-hydroxyprogesterone (17-OHP), hematocrit & prostate specific antigen) at 2, 4 and 6 months. RESULTS: After randomization, 34 participants enrolled in the Testopel® 75mg arm and 42 participants in E100 arm. Serum T levels were similar between the groups at 2, 4 and 6 months, with most men (82%) dropping below 300 ng/dL by the end of the trial. The only adverse event was pellet extrusion (n=1). Most dropouts were related to persistent TD symptoms and serum T < 300ng/dL, with similar rates between the two groups in the study. The mean E levels for Testopel® and E100 at 2 months were 29.1 (IQR: 21.3-35.4) and 42.7±17.3 (IQR: 42.1-48.4) pg/mL respectively (p=0.0006). However, levels were not statistically different at the 4 (p=0.53) and 6-month (p=0.17) time points. Other lab values were similar (Figure 1). CONCLUSIONS: Compounded testosterone pellets are clinically efficacious and safe in the treatment of TD. Compounded pellets may represent an economic alternative to Testopel®. This pilot study may provide the practicing urologist with the support to offer compounded testosterone pellets as TTh. Source of Funding: Investigator-initiated grant by Empower Pharmaceuticals SupportNIH Grant R01 DK130991 and Clinician Scientist Development Grant from the ACS to RR © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1141 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nicholas Deebel More articles by this author Eliyahu Kresch More articles by this author Thiago Fernandes Negris Lima More articles by this author Manuel Molina More articles by this author Rohit Reddy More articles by this author Mehul Patel More articles by this author Justin Loloi More articles by this author Chase Carto More articles by this author Daniel Gonzalez More articles by this author Jesse Ory More articles by this author Halifax Canada 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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.013 | 0.001 |
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".