Not Yet RecruitingPhase 3Phase 4ACTRN12611001031954

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.


Sponsor

AZPA International

Enrollment

80 participants

Start Date

Oct 27, 2011

Study Type

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

Sex: FemalesMin Age: 25 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This double-blind, placebo-controlled study tests whether Testofen, a fenugreek seed extract, can improve sexual function and quality of life in healthy pre-menopausal women aged 25-50. Participants must be in a stable relationship and not have sexual dysfunction at baseline.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Capsules, 2/day Formula: Per capsule: Trigonella foenum-graecum (Fenugreek/Testofen) seed extract, 300mg, gelatin, maltodextrin Daily Dose: 600 mg Fenugreek


Locations(1)

Australia

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ACTRN12611001031954