ACTRN12611001031954尚未招募3 期
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.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 50 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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