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Testosterone therapy randomized controlled trials exhibit suboptimal reporting of adverse events, including polycythemia, gynecomastia, major adverse cardiovascular events, and obstructive sleep apnea

A critical analysis of 30 testosterone therapy (TTh) randomized controlled trials found highly heterogeneous and suboptimal reporting of adverse events. Only 83% measured hematocrit levels, 23% reported baseline values, 17% reported gynecomastia, 20% reported MACE, and 33% mentioned OSA, with few reporting incidence rates. This underscores the need for standardization in TTh trials.

Last updated: Aug 26, 2026•0 RCTs•1 Meta-analyses•📖 Read as article →

Evidence Score

Evidence Score47/100
Human RCT☆☆☆☆☆
Meta-analysis★★★☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. A critical analysis of the quality of testosterone therapy randomized controlled trials.

observational

Furtado TP, Novaes LF, Flores JM, Mulhall JP · Sexual medicine reviews (2026)

Participants: N/A
Duration: N/A
Intervention: Testosterone therapy (TTh) as administered in randomized controlled trials
Outcome: Reporting quality of adverse events: polycythemia (PCT), gynecomastia (GYN), major adverse cardiovascular events (MACE), obstructive sleep apnea (OSA), and hematocrit levels
Effect Size: N/A
Population: Men enrolled in testosterone therapy randomized controlled trials (excluding female and animal studies)

Result:

PubMed: 42636349DOI: 10.1093/sxmrev/qeag064

Mechanism Graph

TTh trials were identified via PubMed search
↓
Trials were assessed for sample size, duration, testosterone levels, and adverse event definitions
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Rates of PCT, GYN, MACE, and OSA were extracted
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Analysis revealed suboptimal and heterogeneous reporting of adverse events

Limitations

  • ⚠Analysis based on published abstracts and trial reports, which may not capture all details
  • ⚠Heterogeneity in adverse event definitions across trials limits comparability
  • ⚠Only 30 trials met inclusion criteria, potentially limiting generalizability

Frequently Asked Questions

What percentage of testosterone therapy RCTs reported baseline hematocrit levels?▼

Only 23% of the included RCTs reported baseline hematocrit values, with a median baseline of 43% and on-treatment median of 45%.

How many testosterone therapy RCTs reported major adverse cardiovascular events (MACE)?▼

Only 20% of the trials reported MACE, and the definitions varied across studies.

What was the median sample size and follow-up duration in the analyzed testosterone therapy RCTs?▼

The median sample size was 76 participants, and the median follow-up was 8 months.

Why is standardization needed in testosterone therapy trials?▼

The analysis found suboptimal and heterogeneous reporting of adverse events, such as gynecomastia and obstructive sleep apnea, which hampers accurate assessment of safety and necessitates standardized reporting guidelines.

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References

  1. 1.Furtado TP, Novaes LF, Flores JM, Mulhall JP. "A critical analysis of the quality of testosterone therapy randomized controlled trials.." Sexual medicine reviews, 2026. PMID: 42636349 DOI: 10.1093/sxmrev/qeag064
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.