Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000925741
Ethics application status
Approved
Date submitted
14/08/2013
Date registered
22/08/2013
Date last updated
30/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 283017 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Andropause 289850 0
Condition category
Condition code
Metabolic and Endocrine 290207 290207 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Capsules, 2/day, Oral administration for 8 weeks

Formula: Per capsule: Trigonella foenum-graecum (Fenugreek/Testofen) seed extract, 300mg, gelatin, maltodextrin

Daily Dose: 600 mg Fenugreek
Intervention code [1] 287737 0
Treatment: Other
Comparator / control treatment
Placebo capsule, Oral administration for 8 weeks

2 capsules/day (same as the active treatment)

Each capsule contains maltodextrin only
Control group
Placebo

Outcomes
Primary outcome [1] 290233 0
Reduction in symptoms of Andropause assessed using the Aging Male Symptoms (AMS) quality of life questionnaire.
Timepoint [1] 290233 0
Basline, 4 weeks and 8 weeks
Secondary outcome [1] 304182 0
Effect on serum testosterone and estrogen levels by assessing serum blood levels of the hormones via blood tests.
Timepoint [1] 304182 0
Baseline and week 8

Eligibility
Key inclusion criteria
Heterosexual male aged between 45-75
Otherwise healthy
Written informed consent from the subject
Minimum age
45 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants are screened by the medicial monitor for inclusion in the study.
The eligible participants are enrolled by Investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the NUMBER.
The investigator is blinded to the product randomized with the numbered containers labelled prior to delivery to Investigational Site.

Product allocated as participants are enrolled in sequential order (1-100).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size
It is constructed to have a population mean score of 50 and a population standard deviation of 10. The test-re-test reliability is documented as approximately 0.8, which implies an error standard deviation in the analysis of covariance of approximately 4.5 (assuming that 80% of the test variance is explained by correlation with the pre-test result).

Given a Holms corrected test procedure, the minimal detectable effect size for a varying sample size is shown in Table 1.


Sample Size (per Group) Minimum Detectable Effect Size
15 5.61
20 4.79
25 4.25
30 3.86

In a study of pre-treatment sexual health in prostate cancer Zinreich et al identified that a score of 48 (i.e. a difference of 2 from the population mean) is functionally normal. The study has therefore been powered to detect a between group difference of 4.


Outcomes
The primary endpoint (questionnaire responses at baseline 4 and 8 weeks) will be analyzed using an analysis of covariance, with baseline (pre-treatment) questionnaire scores as a covariate. Treatment arm will be represented by a factor n the analysis of covariance. Least squares means will be tabulated. Strict control of the family wise type one error rate for multiple time points will be maintained using Holm’s adjustment.

Testosterone and other hormone levels at study termination will be analysed using an analysis of covariance, with baseline and week 8 values as a covariate and study arm as a factor.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2014
Actual
2/02/2014
Date of last participant enrolment
Anticipated
2/07/2014
Actual
2/07/2014
Date of last data collection
Anticipated
Actual
10/08/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7274 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 287784 0
Commercial sector/Industry
Name [1] 287784 0
AZPA International
Country [1] 287784 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AZPA International
Address
48 Translink Drive, Keilor Park Victoria 3042
Country
Australia
Secondary sponsor category [1] 286513 0
Commercial sector/Industry
Name [1] 286513 0
Gencor Nutrients, Inc.
Address [1] 286513 0
920 E. Orangethorpe Avenue
Suite B, Anaheim, CA 92801
Country [1] 286513 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289734 0
Queensland Clinical Trial Network
Ethics committee address [1] 289734 0
Level 3, 88 Jephson Street
Toowong, QLD, 4066
Ethics committee country [1] 289734 0
Australia
Date submitted for ethics approval [1] 289734 0
Approval date [1] 289734 0
22/07/2013
Ethics approval number [1] 289734 0
HREC2013002

Summary
Brief summary
The aim of the study is to assess the herbal formulation in reducing the symptoms of andropause and influencing serum testosterone levels.

The inadequate production of testosterone in men as they age has been associated with Andropause, a variable complex of symptoms, including decreased androgen production, occurring in men after middle age. Andropause has an obvious effect on male sexual health, but may also affect general health in men as they age.

The key features of Andropause include:
Lethargy and fatigue
Diminished sexual desire/libido
Increased abdominal fat (waist circumference greater than 102cm)
Depressed mood or irritability
Decreased cognitive function
Hot flushes or sweating
Decreased lean body mass and muscle volume/strength
Decreased body hair and skin alterations
Low bone mineral density or increased incidence of fractures
Sleep disturbance
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42146 0
Dr Elizabeth Steels
Address 42146 0
Integrated Health Group Pty. Ltd.
362 Water Street
Fortitude Valley Brisbane 4002 QLD
Country 42146 0
Australia
Phone 42146 0
+61 7 31620909
Fax 42146 0
Email 42146 0
research@integratedhealthgroup.com.au
Contact person for public queries
Name 42147 0
Elizabeth Steels
Address 42147 0
Integrated Health Group Pty. Ltd.
P.O. Box 68
New Farm Brisbane 4005 QLD
Country 42147 0
Australia
Phone 42147 0
+61 7 31620909
Fax 42147 0
Email 42147 0
research@integratedhealthgroup.com.au
Contact person for scientific queries
Name 42148 0
Elizabeth Steels
Address 42148 0
Integrated Health Group Pty. Ltd.
P.O. Box 68
New Farm Brisbane 4005 QLD
Country 42148 0
Australia
Phone 42148 0
+61 7 31620909
Fax 42148 0
Email 42148 0
research@integratedhealthgroup.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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