Predictors of clomiphene citrate response in the treatment of men with testosterone deficiency
Abstract
BACKGROUND: Clomiphene citrate (CC) is an established treatment for men with low testosterone, but predictors of treatment response remain poorly defined.
AIM: To identify factors associated with clinically meaningful increases in serum testosterone levels during CC therapy.
METHODS: This retrospective study analyzed men diagnosed with low testosterone and treated with CC. Inclusion criteria were (1) a diagnosis of low testosterone (total testosterone (TT) ≤300 ng/dL with symptoms) or borderline low testosterone (TT 300-400 ng/dL with objective signs of low testosterone (low bone density or elevated HbA1c)), (2) laboratory follow-up within 12-weeks of initiation, and (4) no prior testosterone therapy. Initial CC dosing was 25 mg every other day (QOD), with escalation to 50 mg QOD if TT remained <400 ng/dL. Labs were redrawn every 4-weeks following dose changes until TT was at goal or until CC discontinuation. Discontinuation within 12-weeks without documented response constituted treatment failure. TT was assessed using liquid chromatography-mass spectrometry. Multivariable models were used to identify predictors of treatment response.
OUTCOMES: The primary outcome was achievement of treatment response, defined as TT ≥400 ng/dL on treatment plus an increase in TT ≥200 ng/dL from baseline.
RESULTS: The study included 292 men with median age of 60 (IQR 50, 66) years, median baseline TT (219, 314) 264 ng/dL, and median baseline luteinizing hormone (LH) of 3.5 (2.6, 5.1) mIU/mL.…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 292 participants or records.
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