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.

Completed

• Conditions: Sexual performance; Sexual function; Alternative and Complementary Medicine - Herbal remedies; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12611000830998
• Lead Sponsor: AZPA International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

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.

Exclusion Criteria

Homosexual orientation; Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion; Known hypersensitivity to herbal drugs/nutritional supplement/ foods; Possible physical unavailability of sexual partner during trial period; Any physical disability that may limit sexual function; Received any treatment/therapy for any sexual disorder during last 6 months; Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy; Receiving/ prescribed levodopa (Sinemet) for Parkinson’s Disease or calcipotriene (Dovonex) for Psoriasis; Diagnosed with hypertension and receiving/ prescribed antihypertensive medications; Diagnosed severe renal and/or hepatic insufficiency; Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics; Diagnosed prostatic cancer or benign hypertrophy; if suspected by the investigator, refer for medical assessment; Acute genitourinary disorder; History of genital surgery; Current or history of chronic alcohol and/or drug abuse; Suspected or diagnosed chickpea allergy; Participation in any other clinical trial during last 30 days; Simultaneous participation in another clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Derogatis Interview for Sexual Functioning - Self Report - Male (DISF-SR Male) total score. The DISF-SR (Male) questionnaire is completed by the participant.[Pre-intervention (during the week prior to intervention) and at the end of weeks 2, 4, and 6 (on the last day of each week) during intervention.]