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Completed

NCT Number: NCT04124640

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

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)

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Key information

Conditions

Female Sexual Dysfunction

Age range

45 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 41720, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

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

Other

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.

Primary outcomes

  1. To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.

    Time frame: 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.

Secondary outcomes

  1. Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.

    Time frame: 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

  2. Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.

    Time frame: at 4 months of treatment

    The safety that will be defined by the serious and non-serious adverse reactions collected throughout the study.

  3. Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.

    Time frame: at 2 and 4 months of treatment

    Evaluation of patient satisfaction with treatment using the Likert scale

  4. Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.

    Time frame: 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

  5. 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.

    Time frame: at 0, 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 care

  6. 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.

    Time frame: at 4 months

    Usefulness of using the EVAS-M scale in clinical practice (last visit)

Sponsors and collaborators

Lead sponsor

Procare Health Iberia S.L.

Industry

Registry information

Official study title

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

Acronym: LIBIDOBS

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 11, 2019
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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