NCT04124640

Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.

Observational Study in Real Life to Describe the Effectiveness of LIBICARE® in Women With Low Arousal and Sexual Desire Levels.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: Procare Health Iberia S.L. · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Female Sexual Dysfunction

Interventions

Type	Name	Description
OTHER	Patients' data (baseline characteristics, clinical and outcomes) from routine care visits	Use of a standardized scale to collect clinical and patient-centered data, to assess the effectiveness of Libicare in real life in female 45-65 years old. Patients' data (baseline characteristics, clinical and outcomes) will be collected according to sites routine care.

Timeline

• Start date: 2019-10-29
• Primary completion: 2020-12-31
• Completion: 2021-11-15
• First posted: 2019-10-11
• Last updated: 2022-12-02

Locations

1 site across 1 country: Spain