Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001031954
Ethics application status
Approved
Date submitted
26/09/2011
Date registered
28/09/2011
Date last updated
12/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, randomised, placebo-controlled study to evaluate the effect of Testofen, a specialized extract of Trigonella foenum-graecum (Fenugreek) seed on sexual function and quality of life (QOL) in healthy females.
Scientific title
A double-blind, randomised, placebo-controlled study to evaluate the effect of Testofen, a specialized extract of Trigonella foenum-graecum (Fenugreek) seed on sexual function and quality of life (QOL) in healthy females.
Secondary ID [1] 273123 0
Fenugreek
Universal Trial Number (UTN)
Trial acronym
TFN-FLS11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female sexual function, energy and stamina 270498 0
Condition category
Condition code
Metabolic and Endocrine 270658 270658 0 0
Normal metabolism and endocrine development and function
Alternative and Complementary Medicine 279043 279043 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Capsules, 2/day

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

Daily Dose: 600 mg Fenugreek
Intervention code [1] 269138 0
Treatment: Other
Comparator / control treatment
Placebo capsule, Oral

2 capsules/day (same as the active treatment)

Each capsule contains maltodextrin only
Control group
Placebo

Outcomes
Primary outcome [1] 269377 0
1. Assess efficacy of the Investigational product on sexual function using the DISF-SR (female) and the Female Sexual Function Index (FSFI) at Baseline, week 4 and week 8.
Timepoint [1] 269377 0
Baseline, week 4 and week 8
Secondary outcome [1] 287511 0
Assess efficacy of the Investigational product on individual parameters of female sexual function using the domain and sub domain scores of the DISF-SR (female) and FSFI at Baseline, week 4 and week 8
Timepoint [1] 287511 0
Baseline, 4 weeks, 8 weeks
Secondary outcome [2] 294244 0
Assess the efficacy of the Investigational product on frequency of sexual encounters using participant diary and DISF-SR Question 3.5
Timepoint [2] 294244 0
Baseline and 8 weeks
Secondary outcome [3] 294245 0
Assess the efficacy of the Investigational product on quality of current sexual functioning using DISF-SR Question 5.4
Timepoint [3] 294245 0
Baseline and 8 weeks
Secondary outcome [4] 294246 0
Assess the efficacy of the Investigational product on reducing fatigue using the Multi-dimensional Fatigue Symptom Inventory (MFSI); total, general, emotional, physical, mental and vigor
Timepoint [4] 294246 0
Baseline and 8 weeks
Secondary outcome [5] 294247 0
Assess the efficacy of the Investigational product on reducing stress using the Perceived Stress Scale (PSS).
Timepoint [5] 294247 0
Base and 8 weeks
Secondary outcome [6] 294248 0
7. Assess sex steroid levels at Baseline and at week 8 of treatment;
I. Total testosterone
II. Free testosterone
III. Sex hormone binding globulin (SHBG)
IV. Estradiol (E2)
V. Androstenedione
VI. Dehydroepiandrosterone (DHEA)
VII. Follicle Stimulating Hormone (FSH)
VIII. Luteinizing Hormone (LH)
IX. Progesterone
X. Prolactin
Timepoint [6] 294248 0
Baseline and 8 weeks
Secondary outcome [7] 294249 0
Assess the efficacy of Investigational product on general health parameters; weight, basal metabolic rate (BMI), and sleep.
Timepoint [7] 294249 0
Baseline and 8 weeks
Secondary outcome [8] 294250 0
Explore potential correlations between libido and relational intimacy measured by Dimensional Relationship Quality (DRQ) at baseline and week 8
Timepoint [8] 294250 0
Baseline and 8 weeks
Secondary outcome [9] 294251 0
Explore correlations between libido and non-sexual variables at baseline: age, weight, BMI, levels and type of exercise, hours of sleep/night, alcohol intake, number of children, length of time in current relationship and income levels
Timepoint [9] 294251 0
Baseline and 8 weeks
Secondary outcome [10] 294252 0
Safety and tolerability to be determined by electrolyte/liver function test (E/LFT), Full Blood Count (FBC), sex hormone levels, and participant reporting of their menstrual cycle pattern and any adverse events
Timepoint [10] 294252 0
Baseline and 8 weeks

Eligibility
Key inclusion criteria
Eligible women must be:
25-50 years old and in generally good health
Pre-menopausal with normal cycles (28-34 day cycles)
On Contraceptive pill and/or actively using contraception for at least 3 months
In her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative
Believe that sexual problems were not to be considered caused by relationship/partner problems.
Score > 26 on the FSFI (clinical cut-off point for not being sexually dysfunction). (Weigel et al 2005).
Partner with normal libido and prepared to answer a questionnaire at completion of the study (posted questionnaire with pre-paid return envelope).
Able to adhere to protocol requirements
Able to give informed consent
Minimum age
25 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Eligible women must not:
Have received androgen therapy at any time during the past 3 months
Be pregnant or attempting to conceive
Be breastfeeding or be lactating for at least 3 months prior to study
Be experiencing any chronic or acute life stress relating to any major life change
Be experiencing depression and/or receiving medication for such illness or disorder
Be receiving statins or other drugs known to impact on steroid hormone levels
Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
Be on medication for diabetes
Have a history of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
Taking any of these drugs that have anticoagulation and antiplatelet effects on a daily basis for any conditions: aspirin, diclofenac (Voltaren, Clonac, Diclohexal, Dinac, Fenac), meloxicam (Mobic, Movalis), piroxicam (Mobilis, Feldene), ibuprofen (Brufen, Rafen, Neurofen), and naproxen (Proxen, Naprosyn, Inza, Crysanal, Naprogesic).
Have abnormal laboratory test results upon initial screening for this study
Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 daysAllergy to fenugreek or any of the excipients or ingredients in this capsule.
Have abnormal laboratory test results for this study

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 (1-80).
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?



Intervention assignment
Parallel
Other design features
RCT
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269613 0
Commercial sector/Industry
Name [1] 269613 0
AZPA International
Country [1] 269613 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AZPA International
Address
48 Translink Drive, Keilor Park Victoria 3042 Australia
Country
Australia
Secondary sponsor category [1] 266646 0
Commercial sector/Industry
Name [1] 266646 0
Gencor Nutrients, Inc.
Address [1] 266646 0
920 E. Orangethorpe Avenue
Suite B, Anaheim, CA 92801
Country [1] 266646 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269560 0
Queensland Clinical Trial Network
Ethics committee address [1] 269560 0
Level 3, 88 Jephson Street
Toowong, QLD, 4066
Ethics committee country [1] 269560 0
Australia
Date submitted for ethics approval [1] 269560 0
Approval date [1] 269560 0
13/09/2011
Ethics approval number [1] 269560 0
QCTN HREC Number: 2011001

Summary
Brief summary
This is a double-blind, randomised, placebo-controlled study to evaluate the efficacy of an orally-dosed herb Fenugreek seed extract, on libido and general quality of life in healthy women.

We are looking to see if the herbal medicine can change libido, weight, stress levels, and energy levels over 2 menstrual cycles (approximately 8 weeks). We are also looking to see if there is any change in hormone levels after taking the herbal medicine for the 8 weeks.

In this type of study, we use a placebo as the control group (only contains inactive ingredients) to determine if the product is effective. Participation in the study will last approximately 10 weeks. Participants will be asked to take the medication for 8 weeks, exactly 2 menstrual cycles, with questionnaires and a blood test at the beginning and follow-up at week 4 and week 8.

This kind of treatment assignment and randomization (study herb selection by chance) are only carried for research studies. These procedures are being performed for the purposes of the study and are not part of your routine care. The chance of you receiving the active treatment is 50%.
Trial website
Recruitment: http://www.trialfacts.com - Click on ASN female libido study.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32535 0
Address 32535 0
Country 32535 0
Phone 32535 0
Fax 32535 0
Email 32535 0
Contact person for public queries
Name 15782 0
Amanda Rao
Address 15782 0
P.O. Box 68
New Farm Brisbane
QLD 4005
Country 15782 0
Australia
Phone 15782 0
+61 7 3162 0909
Fax 15782 0
Email 15782 0
[email protected]
Contact person for scientific queries
Name 6710 0
Dr. Beth Steels
Address 6710 0
P.O. Box 68
New Farm Brisbane
QLD 4005
Country 6710 0
Australia
Phone 6710 0
+61 7 3162 0909
Fax 6710 0
Email 6710 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
SourceTitleYear of PublicationDOI
EmbaseInfluence of a Specialized Trigonella foenum-graecum Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study.2015https://dx.doi.org/10.1002/ptr.5355
N.B. These documents automatically identified may not have been verified by the study sponsor.