Association Between Trial Duration and Completion Rate in Men's Health Clinical Trials, 2005–2024

Clinical trials drive evidence generation in men's health, yet temporal patterns in trial duration and completion remain poorly characterized. We examined relationships between trial duration, completion rates, and trial characteristics in men's health research registered over two decades. We conducted a cross‐sectional analysis of 5401 men's health clinical trials registered on ClinicalTrials.gov ClinicalTrials.gov between January 2005 and December 2024. Trials were identified using systematic Medical Subject Heading (MeSH) terms, including but not limited to hypogonadism, erectile dysfunction, infertility, benign prostatic hyperplasia, and prostate cancer. Primary outcomes were trial duration and completion status. Multivariable linear regression quantified associations between duration and calendar year, trial phase, funding source, and enrollment. Multivariable logistic regression evaluated predictors of trial completion. Median trial duration was 730 days (IQR: 365–1370). Trial duration decreased by 46 days annually ( β  = −46.16 days/year; p  < 0.01; R ²  = 0.06), representing approximately 920 fewer days over the study period. Completion rates declined concurrently, with 14% lower annual odds of completion (OR = 0.86/year; p  < 0.01). Longer duration independently predicted non‐completion (OR = 0.89/day; p  < 0.01). Phase 2 trials were 353 days longer than not applicable phase trials ( p  < 0.01). NIHNIH‐funded‐funded trials exceeded industry‐funded trials by 1401 days ( p  < 0.01), while network‐funded trials were 1333 days longer ( p  < 0.01). Only 774 trials (14%) reported results despite regulatory requirements. Men's health trials demonstrate declining duration yet paradoxically decreasing completion rates over two decades. Funding source substantially influences trial timelines. Low results reporting limits evidence accessibility. These patterns may constrain the scope of feasible research innovation in men's health.

Level of Evidence

Level III.