Clinical trial NCT04124640: Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.
Official title: Observational Study in Real Life to Describe the Effectiveness of LIBICARE® in Women With Low Arousal and Sexual Desire Levels.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Sexual Dysfunction
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 185
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal

Brief 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.

Eligibility criteria: 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®

Primary outcomes:
measure: To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.
timeFrame: 4 month
Secondary outcomes:
measure: Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
timeFrame: at 2 and 4 months of treatment
measure: Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.
timeFrame: at 4 months of treatment
measure: Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
timeFrame: at 2 and 4 months of treatment
measure: Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
timeFrame: at 2 and 4 months of treatment
measure: 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.
timeFrame: at 0, 2 and 4 months of treatment
measure: 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.
timeFrame: at 4 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
Study officials:
affiliation: Procare health Iberia
name: Josep Combalia, MD
role: STUDY_DIRECTOR
affiliation: Instituto Palacios de Salud y Medicina de la Mujer.
name: Santiago Palacios
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rao A, Steels E, Beccaria G, Inder WJ, Vitetta L. Influence of a Specialized Trigonella foenum-graecum Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study. Phytother Res. 2015 Aug;29(8):1123-30. doi: 10.1002/ptr.5355. Epub 2015 Apr 24.
citation: Akhtari E, Raisi F, Keshavarz M, Hosseini H, Sohrabvand F, Bioos S, Kamalinejad M, Ghobadi A. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study. Daru. 2014 Apr 28;22(1):40. doi: 10.1186/2008-2231-22-40.
citation: Zhao J, Dasmahapatra AK, Khan SI, Khan IA. Anti-aromatase activity of the constituents from damiana (Turnera diffusa). J Ethnopharmacol. 2008 Dec 8;120(3):387-93. doi: 10.1016/j.jep.2008.09.016. Epub 2008 Sep 26.