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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal
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| Name | Affiliation | Role |
|---|---|---|
| Josep Combalia, MD | Procare health Iberia | Study Director |
| Santiago Palacios | Instituto Palacios de Salud y Medicina de la Mujer. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Palacios de Salud y Medicina de la Mujer | Madrid | 41720 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25914334 | Result | 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. | |
| 24773615 |
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| ID | Term |
|---|---|
| D016896 | Treatment Outcome |
| ID | Term |
|---|---|
| D011379 | Prognosis |
| D003933 | Diagnosis |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
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|
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 |
| 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. |
| 18948180 | Result | 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. |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D017530 | Health Care Quality, Access, and Evaluation |