Observational Study in Real Life to Describe the Effectiveness of LIBICARE® in Women With Low Arousal and Sexual Desire Levels.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.
研究概览
简要总结
The decrease or absence sexual desire and arousal is the alteration of the sexual sphere that women most commonly refer to in adulthood and old age. Many women can refer a decrease or absence of desire and / or arousal without having the disorder typified in the DSM-5, but that can cause discomfort, worry and relationship problems in their day to day. Libicare® is a food supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels. The main ingredients of Libicare® are:
- Trigonella Foenum-graecum (Trigonella) (1)
- Tribulus Terrestris (Tribulus) (2)
- Turnera Diffusa (Damiana) (3)
详细描述
The main objective is to describe the effectivity of LIBICARE® in the improvement of desire and sexual arousal in women between 45 and 65 years old, in real life.
The secondary objectives of the study are:
- Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
- Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse events.
- Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
- Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
- Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.
- To evaluate the degree of usefulness of the EVAS-M scale in clinical practice after 4 months of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 between 45 and 65 years old, both ages included.
- •Women who refer decreased desire and / or sexual arousal.
- •Women who will receive LIBICARE® by prescription of their doctor regardless of their participation or not in the study.
- •Women who have given their informed consent in writing.
排除标准
- •Women who suffer or have suffered breast cancer.
- •Women in anticoagulant treatment.
- •Women who, in the opinion of the researcher, cannot follow the study procedures.
- •Women not be able to understand the nature of the study, the procedures to follow or who are not authorized to sign an informed consent
- •Pregnant or lactating women
- •Women with allergies to any of the components of Libicare®
结局指标
主要结局
To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.
时间窗: 4 month
The effectiveness will be the increase in the score of the EVAS-M scale that will be provided to patients in the visita during the follow-up visits.
次要结局
- Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.(at 4 months of treatment)
- Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.(at 2 and 4 months of treatment)
- To evaluate the degree of usefulness of the EVAS-M (ESCALA DE VALORACION DE LA ACTIVIDAD SEXUAL in Spanish) scale in clinical practice after 4 months of treatment.(at 4 months)
- Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.(at 2 and 4 months of treatment)
- Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.(at 2 and 4 months of treatment)
- Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.(at 0, 2 and 4 months of treatment)