Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000830998
Ethics application status
Approved
Date submitted
4/11/2008
Date registered
5/08/2011
Date last updated
8/08/2011
Type of registration
Retrospectively 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 sexual function, performance, and serum testosterone levels in healthy males.
Scientific title
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.
Secondary ID [1] 262790 0
Nil
Universal Trial Number (UTN)
Trial acronym
TFN-SFN08
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual performance 3921 0
Sexual function 3922 0
Condition category
Condition code
Alternative and Complementary Medicine 4115 4115 0 0
Herbal remedies
Metabolic and Endocrine 270657 270657 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 3640 0
Treatment: Other
Comparator / control treatment
Placebo tablet containing rice bran, cellulose-microcrystalline, and calcium hydrogen phosphate, croscarmellose sodium, crospovidone, povidone, ethylcellulose, iron oxide, hypromellose, silicon dioxide, magnesium stearate, and coating (opadry II and carnuba wax). This control tablet is dosed as per the investigational product.
Control group
Placebo

Outcomes
Primary outcome [1] 5006 0
Derogatis Interview for Sexual Functioning - Self Report - Male (DISF-SR Male) total score. The DISF-SR (Male) questionnaire is completed by the participant.
Timepoint [1] 5006 0
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.
Secondary outcome [1] 8449 0
Serum testosterone, determined by laboratory serum analysis.
Timepoint [1] 8449 0
Blood collection will occur at pre-intervention (within the week prior to intervention) and completion of intervention (during the last two days of intervention).
Secondary outcome [2] 8450 0
Serum prolactin, determined by laboratory serum analysis.
Timepoint [2] 8450 0
Blood collection will occur at pre-intervention (within the week prior to intervention) and completion of intervention (during the last two days of intervention).
Secondary outcome [3] 8451 0
Serum prostate specific antigen (PSA), determined by laboratory serum analysis.
Timepoint [3] 8451 0
Blood collection will occur at pre-intervention (within the week prior to intervention) and completion of intervention (during the last two days of intervention).
Secondary outcome [4] 8452 0
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.
Timepoint [4] 8452 0
As per the primary outcome: 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.
Secondary outcome [5] 8453 0
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?").
Timepoint [5] 8453 0
During the exit interview, which is conducted during the week subsequent to conclusion of intervention.

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269612 0
Commercial sector/Industry
Name [1] 269612 0
AZPA International
Country [1] 269612 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AZPA International
Address
17 Concord Drive
Keilor Park VIC 3042
Country
Australia
Secondary sponsor category [1] 3695 0
Commercial sector/Industry
Name [1] 3695 0
Totally Natural Products
Address [1] 3695 0
13-14 Durian Place
Wetherill Park NSW 2164
Country [1] 3695 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6178 0
Queensland Clinical Trial Network (QCTN)
Ethics committee address [1] 6178 0
Ethics committee country [1] 6178 0
Australia
Date submitted for ethics approval [1] 6178 0
08/09/2008
Approval date [1] 6178 0
13/10/2008
Ethics approval number [1] 6178 0
HREC-001

Summary
Brief summary
This trial is being undertaken to assess whether the herbal formulation containing Testofen improves general sexual function, performance, and satisfaction in healthy males.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29092 0
Address 29092 0
Country 29092 0
Phone 29092 0
Fax 29092 0
Email 29092 0
Contact person for public queries
Name 12249 0
Amanda Rao
Address 12249 0
PO Box 68
New Farm QLD 4005
Country 12249 0
Australia
Phone 12249 0
+61 7 3162 0909
Fax 12249 0
Email 12249 0
[email protected]
Contact person for scientific queries
Name 3177 0
Dr. Beth Steels
Address 3177 0
PO Box 68
New Farm QLD 4005
Country 3177 0
Australia
Phone 3177 0
+61 7 3162 0909
Fax 3177 0
Email 3177 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.