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

Procare Health

Status: Completed

Conditions: Female Sexual Dysfunction

Treatments: Other: Patients' data (baseline characteristics, clinical and outcomes) from routine care visits

Study type: Observational

Funder types: Industry

Identifiers

NCT04124640

PRO-LIB-2019-01

Details and patient eligibility

About

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)

Full 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.

Enrollment: 185 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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®

Trial design

185 participants in 1 patient group

treatment group

Description:

The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal

Treatment:

Other: Patients' data (baseline characteristics, clinical and outcomes) from routine care visits