A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal formulation containing Testofen, on sexual function, performance, and serum testosterone levels in healthy males.

INTERVENTION: Tablet‐form herbal formulation containing Trigonella foenum‐graecum seed extract (equivalent to 9900 mg), magnesium aspartate (equivalent to Mg 15.17 mg), zinc amino acid chelate (equivalent to Zn 15 mg) and vitamin B6 (equivalent to pyridoxine 4.94 mg). Dosing is one tablet, twice per day, by‐mouth: one hour before the morning meal (breakfast) and one hour before the evening meal (dinner) for a total of 2 tablets per day, for the duration of the trial (6 weeks). CONDITION: Sexual function Sexual performance PRIMARY OUTCOME: Derogatis Interview for Sexual Functioning ‐ Self Report ‐ Male (DISF‐SR Male) total score. The DISF‐SR (Male) questionnaire is completed by the participant. SECONDARY OUTCOME: DISF‐SR (male) domain subscores: sexual cognition/fantasy; sexual arousal; sexual behaviour/experiences; and orgasm. The DISF‐SR (Male) questionnaire is completed by the participant. General libido improvement. The participant will be asked a global efficacy question ("Do you feel that the medication you have been taking for the last six weeks improved your libido?"). Serum prolactin, determined by laboratory serum analysis. Serum prostate specific antigen (PSA), determined by laboratory serum analysis. Serum testosterone, determined by laboratory serum analysis. INCLUSION CRITERIA: Heterosexual; Stable sexual relationship for at least the last 6 months; Sexually active for at least the last 6 months; Anticipated stable sexual relationship for at least the next 8 weeks; Sexual partner willing to provide information during interviews; Written informed consent from the subject.