ANZCTR - Registration

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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

Secondary ID [1]

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

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Alternative and Complementary Medicine

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]

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]

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]

Baseline, week 4 and week 8

Secondary outcome [1]

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]

Baseline, 4 weeks, 8 weeks

Secondary outcome [2]

Assess the efficacy of the Investigational product on frequency of sexual encounters using participant diary and DISF-SR Question 3.5

Timepoint [2]

Baseline and 8 weeks

Secondary outcome [3]

Assess the efficacy of the Investigational product on quality of current sexual functioning using DISF-SR Question 5.4

Timepoint [3]

Baseline and 8 weeks

Secondary outcome [4]

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]

Baseline and 8 weeks

Secondary outcome [5]

Assess the efficacy of the Investigational product on reducing stress using the Perceived Stress Scale (PSS).

Timepoint [5]

Base and 8 weeks

Secondary outcome [6]

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]

Baseline and 8 weeks

Secondary outcome [7]

Assess the efficacy of Investigational product on general health parameters; weight, basal metabolic rate (BMI), and sleep.

Timepoint [7]

Baseline and 8 weeks

Secondary outcome [8]

Explore potential correlations between libido and relational intimacy measured by Dimensional Relationship Quality (DRQ) at baseline and week 8

Timepoint [8]

Baseline and 8 weeks

Secondary outcome [9]

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]

Baseline and 8 weeks

Secondary outcome [10]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

AZPA International

Address [1]

48 Translink Drive, Keilor Park Victoria 3042

Country [1]

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]

Commercial sector/Industry

Name [1]

Gencor Nutrients, Inc.

Address [1]

920 E. Orangethorpe Avenue
Suite B, Anaheim, CA 92801

Country [1]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland Clinical Trial Network

Ethics committee address [1]

Level 3, 88 Jephson Street
Toowong, QLD, 4066

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/09/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Amanda Rao

Address

P.O. Box 68
New Farm Brisbane
QLD 4005

Country

Australia

Phone

+61 7 3162 0909

Fax

amanda@asnresearch.com.au

Contact person for scientific queries

Name

Dr. Beth Steels

Address

P.O. Box 68
New Farm Brisbane
QLD 4005

Country

Australia

Phone

+61 7 3162 0909

Fax

beth@asnresearch.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Influence of a Specialized Trigonella foenum-graecum Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study.	2015	https://dx.doi.org/10.1002/ptr.5355

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically