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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124640
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Procare Health Iberia S.L.

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)

Condition or disease Intervention/treatment
Female Sexual Dysfunction 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 every domain of the EVAS-M scale during the study period
  • Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse events during the study treatment.
  • Evaluation of patient satisfaction with treatment
  • Therapeutic compliance.
  • Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG.
  • To evaluate the range of utility of the EVAS-M scale

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Observational Study in Real Life to Describe the Effectiveness of LIBICARE® in Women With Low Arousal and Sexual Desire Levels.
Actual Study Start Date : October 29, 2019
Estimated Primary Completion Date : June 29, 2020
Estimated Study Completion Date : December 10, 2020

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.




Primary Outcome Measures :
  1. Percentage of women who increase EVAS-M scale score [ Time Frame: 4 month ]
    The effectiveness will be assessed by the increase in the score of the EVAS-M scale that will be provided to patients during routine visits. The increase in the score of the EVAS-M scale ("Escala de Valoración de la Actividad Sexual en la mujer" in Spanish) will be measured by the percentage of women who increase score (score from 2 to 60 points)

  2. Change / absolute increase (final-baseline difference) of the EVAS-M scale score [ Time Frame: 4 month ]
    The effectiveness will be assessed by the increase in the score of the EVAS-M scale ("Escala de Valoración de la Actividad Sexual en la mujer" in Spanish) that will be provided to patients during routine visits. The increase in the score of the EVAS-M scale will be measured by change / absolute increase (final-baseline difference) of the score (score from 2 to 60 points)

  3. Change / relative increase (% change / increase over baseline) of the EVAS-M scale score [ Time Frame: 4 month ]
    The effectiveness will be assessed by the increase in the score of the EVAS-M scale ("Escala de Valoración de la Actividad Sexual en la mujer" in Spanish) that will be provided to patients during routine visits. The increase in the score of the EVAS-M scale will be measured by change / relative increase (% change / increase over baseline) of the score (from 2 to 60 points)


Secondary Outcome Measures :
  1. Evaluation of the 6 domains of the EVAS-M scale [ 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. SAEs and AEs [ Time Frame: during 4 month ]
    Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse events

  3. Evaluation of treatment patient satisfaction [ Time Frame: at 2 and 4 months of treatment ]
    Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment using a Likert scale

  4. Therapeutic compliance [ Time Frame: at 2 and 4 months of treatment ]
    Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment using a Likert scale

  5. Hormonal variation [ 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. utility of the EVAS-M scale [ Time Frame: at 4 month ]
    To evaluate the range of utility of the EVAS-M scale ("Escala de Valoración de la Actividad Sexual en la mujer" in Spanish) in clinical routine care after 4 months of treatment using a 4-points Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
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.

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®
  • Women who have given written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124640


Contacts
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Contact: Josep Combalia, MD +34 936 45 54 41 combalia.j@procarehealth.com

Locations
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Spain
Instituto Palacios de Salud y Medicina de la Mujer Recruiting
Madrid, Spain, 41720
Contact: Santiago Palacios, MD         
Sponsors and Collaborators
Procare Health Iberia S.L.
Investigators
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Study Director: Josep Combalia, MD Procare health Iberia
Principal Investigator: Santiago Palacios Instituto Palacios de Salud y Medicina de la Mujer.
Publications of Results:
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Responsible Party: Procare Health Iberia S.L.
ClinicalTrials.gov Identifier: NCT04124640    
Other Study ID Numbers: PRO-LIB-2019-01
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No