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.
AZPA International
80 participants
Oct 27, 2011
Interventional
Conditions
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%.
Eligibility
Inclusion Criteria10
- Eligible women must be:
- -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
Exclusion Criteria15
- 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
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Interventions
Capsules, 2/day Formula: Per capsule: Trigonella foenum-graecum (Fenugreek/Testofen) seed extract, 300mg, gelatin, maltodextrin Daily Dose: 600 mg Fenugreek
Locations(1)
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ACTRN12611001031954