A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal formulation containing Testofen, on symptoms of Andropause and serum testosterone levels in otherwise healthy males aged between 45-75 years.

Phase 3

Completed

• Conditions: Andropause; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12613000925741
• Lead Sponsor: AZPA International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Heterosexual male aged between 45-75
Otherwise healthy
Written informed consent from the subject

Exclusion Criteria

Subjects will be excluded for any one of the following reasons:
Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
Known hypersensitivity to herbal drugs/nutritional supplement/ foods
Any physical disability that may limit sexual function or erectile dysfunction
Received any treatment/therapy I(including testosterone) for any sexual disorder during last 6 months
Receiving/ prescribed coumandin (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
Reduction in symptoms of Andropause assessed using the Aging Male Symptoms (AMS) quality of life questionnaire.[Basline, 4 weeks and 8 weeks]

Secondary Outcome Measures

Name	Time	Method
Effect on serum testosterone and estrogen levels by assessing serum blood levels of the hormones via blood tests.[Baseline and week 8]