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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-29

Study Completion Date

2021-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels

NCT04188600

Female Sexual Interest/Arousal Disorder

WITHDRAWN NA

Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems

NCT01743235

Hypoactive Sexual Desire Disorder

COMPLETED PHASE2

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

NCT00612742

Hypoactive Sexual Desire Disorder

COMPLETED PHASE3

Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy

NCT04766957

Vulvovaginal Atrophy

COMPLETED NA

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

NCT00657501

Hypoactive Sexual Desire Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Sexual Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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®

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No