National, Multicentric, Randomized, Single-blind, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Evolution of sexual desire and arousal
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.
详细描述
The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.
Despite current consensus in the literature that Female Sexual Dysfunction can manifest at any age in a woman´s life, researchers as Sarrel documented that during menopause, up to 40% of women are experiencing a decrease in their sexual libido. The common assumption is that the menopause contributes to a drop of the sexual desire probably as a result of low production of hormones from ovaries, at the same time will reduce the estrogen and testosterone. This reduction starts to be reduced in the thirties and continues to reduce progressively at a constant rate reaching of about 50% of their initial highest levels by the time they reach menopause. Other hormones could be involved as Sex hormone-binding globulin (SHBG) or dehydroepiandrosterone (DHEA), both are related with testosterone levels.
Libicare® is a dietary supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels.
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)
盲法说明
The analysis of the results will be blind for the investigator
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged between 40 and 60 years old.
- •Healthy peri or postmenopausal women.
- •Body Mass Index (BMI) between 18,5-29,
- •Female with low sexual desire and low arousal with a score ≤26.55 on the questionnaire Female Sexual Function Index (FSFI) .
- •Patients who signed the Informed Consent Form.
排除标准
- •Female with uncontrolled thyroid function.
- •Female with severe genital pain (vaginism, stopping intercourse because of severe pain).
- •Female diagnosed with primary female orgasmic disorder.
- •No coital intercourse a month.
- •Lack of steady sexual partner.
- •Suffering from any serious medical condition (any disease which may force the participant to use drug during the study).
- •Suffering from major depression disorder or other psychiatric disorders.
- •Women on anticoagulant treatment.
结局指标
主要结局
Evolution of sexual desire and arousal
时间窗: 12 weeks
The evolution of the composite score from sexual desire and arousal obtained using FSFI (Female Sexual Function Index) questionnaire. It has 19 questions with six domains included desire, arousal, lubrication, orgasm, satisfaction and pain, and a general score in which higher scores reflected better sexual activity.
次要结局
- The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL©(at 6, 12 and 24 weeks)
- The evolution of other each sexual FSFI domain score(at 6, 12 and 24 weeks)
- To evaluate the hormonal levels (free testosterone and SHBG)(at 6, 12 and 24 weeks)
- Clinical satisfaction of the women with the treatment, using a Likert-type scale(at 6, 12 and 24 weeks)
- The evolution of the composite score from sexual desire and arousal(at 6 and 24 weeks)
- The evolution of the FSFI questionnaire total score(at 6, 12 and 24 weeks)
- The improvement in the Quality of life of women by EQ-5D-5L questionnaire(at 12 and 24 weeks)
- Weight, height and BMI(at baseline, 6, 12 and 24 weeks)
- Adverse events and adverse drug reactions(at 6, 12 and 24 weeks.)
- The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire(at 12 and 24 weeks)
- The evaluation of the degree of therapeutic compliance(at 6, 12 and 24 weeks)