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

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

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)

Study Overview

• Status: Completed
• Conditions: Female Sexual Dysfunction
• Intervention / Treatment: Other: Patients' data (baseline characteristics, clinical and outcomes) from routine care visits

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.

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 41720
    • Instituto Palacios de Salud y Medicina de la Mujer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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®

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
treatment group; The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.	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.	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.	Evaluation of the 6 domains of the EVAS-M scale ("Escala de Valoración de la Actividad Sexual en la mujer" in Spanish, score from 2 to 60 points) at 2 and 4 months of treatment	at 2 and 4 months of treatment
Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.	The safety that will be defined by the serious and non-serious adverse reactions collected throughout the study.	at 4 months of treatment
Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.	Evaluation of patient satisfaction with treatment using the Likert scale	at 2 and 4 months of treatment
Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.	Therapeutic compliance will continue to be adjusted as much as possible to routine clinical practice using the Likert scale	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.	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 care	at 0, 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.	Usefulness of using the EVAS-M scale in clinical practice (last visit)	at 4 months

Collaborators and Investigators

• Sponsor: Procare Health Iberia S.L.
• Investigators: Study Director: Josep Combalia, MD, Procare Health Iberia; Principal Investigator: Santiago Palacios, Instituto Palacios de Salud y Medicina de la Mujer.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PRO-LIB-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No