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.
- Conditions
- Female sexual function, energy and staminaMetabolic and Endocrine - Normal metabolism and endocrine development and functionAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12611001031954
- Lead Sponsor
- AZPA International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 80
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method