Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Changes of Score on the Female Sexual Function Index (FSFI)
研究概览
简要总结
This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- •Post-menopause.
- •Age between 45 and 65 years.
- •Sexually active.
- •Agreement to participate and to sign the informed consent documents.
排除标准
- •Pregnancy.
- •Women who are on hormone replacement therapy or who need to start it.
- •Cancer treatment or a recent history of cancer (<2 years).
- •Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible)
- •Fibromyalgia.
- •Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.).
- •Any comorbidity that may interfere with the pathology under study.
研究组 & 干预措施
Control group
One tablet per day in the morning through oral administration of Placebo. During three months.
干预措施: Placebo treatment (Other)
Active group
One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months.
干预措施: Tribulus Terrestris (Dietary Supplement)
结局指标
主要结局
Changes of Score on the Female Sexual Function Index (FSFI)
时间窗: At baseline, at 6 weeks, at 3 months and at 6 months (optional)
Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido. The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome. Scale subdomains, their scoring range and factor to the total score is the following: Domain: Desire, Range \[1 - 5\] Factor: 0.6 Domain: Arousal, Range \[0 - 5\] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range \[0 (or 1) - 5 \] Factor: 0.4 Domain: Pain Range \[0-5\] Factor: 0.4
次要结局
- Compliance with treatment - Measured with the Morisky-Green scale(3 months)
- Compliance with treatment -Therapeutic adherence(3 months)
- Variations in testosterone levels (total, bioavailable, and free)(Change from baseline to 3 months visit)
- Number of adverse events(Thought the study, an average of 10 months.)
- Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.(Change from baseline, to 3 months and optional visit at 6 months)
- Compliance with treatment - Recount of refounded product by patient.(3 months)