(064) 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
Abstract Introduction Testosterone deficiency (TD) is a prevalent condition, especially in men ≥ 45 years old, and testosterone therapy (TTh) can improve quality of life in these patients. Objective In this abstract, we aim to evaluate the safety profile of compounded subcutaneous testosterone pellets and to compare the pharmacokinetics between compounded and FDA approved testosterone pellets (Testopel®) for TTh. Methods This was a prospective, Phase 3, 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. The patients were implanted with their respective treatment: Testopel® (10 pellets of 75mg) or compounded testosterone pellets (8 pellets of 100mg). Results After randomization, there were 35 participants enrolled in the Testopel® 75mg arm and 40 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. Adverse events such as elevations in prostate specific antigen, estrogen and hematocrit in each group were similar. Most dropouts were related to persistent TD symptoms and serum T < 300ng/dL, with similar rates between the two groups in the study. Conclusions Men treated with Testopel® and compounded pellets had comparable serum testosterone levels and similar adverse events rates. Compounded testosterone pellets can provide an effective choice of long term TTh among men with TD comparable to Testopel®. Disclosure Yes, this is sponsored by industry/sponsor: Empower Pharmaceuticals. Clarification Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Empower Pharmacy.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 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) | 0.008 | 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".