The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal

Female Sexual Dysfunction

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.

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

Instituto Palacios de Salud y Medicina de la Mujer

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

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

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)

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)

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)

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

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 using a Likert scale

Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment using a Likert scale

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

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

Procare Health Iberia S.L.

Fenugreek seeds extract 500 mg capsule twice a day for 12 weeks

Placebo capsule containing Dicalcium Phosphate 500mg, BD

Diabetes

Fenugreek seeds extract

Placebo

Evaluation of Fenugreek Seed Extract In Type- 2 Diabetes: An Add-On Study

Clinical Evaluation of Fenugreek Seed Extract In Patients With Type- 2 Diabetes: An Add-On Study

Reduction in fasting blood sugar levels (FBS) (mg/dL)

Reduction in post prandial blood sugar levels (mg/dL)

Chemical Resources

Phase 1 (run-in): Marevan®
Phase 2: Marevan®
Phase 3: generic warfarin #1
Phase 4: generic warfarin #2

Phase 1 (run-in): generic warfarin #1
Phase 2: generic warfarin #1
Phase 3: Marevan®
Phase 4: generic warfarin #2

Phase 1 (run-in): generic warfarin #1
Phase 2: generic warfarin #1
Phase 3: generic warfarin #2
Phase 4: Marevan®

Phase 1 (run-in): Marevan®
Phase 2: Marevan®
Phase 3: generic warfarin #2
Phase 4: generic warfarin #1

Phase 1 (run-in): generic warfarin #2
Phase 2: generic warfarin #2
Phase 3: Marevan®
Phase 4: generic warfarin #1

Phase 1 (run-in): generic warfarin #2
Phase 2: generic warfarin #2
Phase 3: generic warfarin #1
Phase 4: Marevan®

Atrial Fibrillation

Branded warfarin sodium tablets (manufacturer União Química Farmacêutica Nacional S/A, Brazil) by mouth; dose adjusted according to INR and medical judgement.

Marevan®

Generic warfarin sodium tablets, manufacturer (União Química Farmacêutica Nacional S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

generic warfarin #1

Generic warfarin sodium tablets, manufacturer (Laboratório Teuto Brasileiro S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

generic warfarin #2

Hospital São Paulo/Hospital Universitário da UNIFESP (University Hospital of UNIFESP)

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Therapeutic Equivalence Between Branded and Generic Warfarin Sodium Tablets in Adult Patients With Atrial Fibrillation in Brazil - Crossover Randomized Controlled Equivalence Trial

INR: International normalized ratio. INR will be assessed twice a month during the 16 weeks of study.
Delta INR will be calculated by the difference, in absolute numbers (i.e. in module), between the two valid INR measurements due for each patient with each formulation at each period. Difference between the delta INRs will be the outcome. We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

INR: International normalized ratio. INR will be assessed twice a month during the 16 weeks of study.
We will calculate the mean INR for each formulation of warfarin; difference between the mean INRs will be the outcome. We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

The warfarin dosage will be calculated as the sum of the dosage taken in the week before the study visit, as referred by the patient. We will calculate the mean dosage for each formulation of warfarin; difference between the mean dosage will be the outcome.
We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

Includes ischemic stroke (differential diagnosis with hemorrhagic stroke by tomography) and thromboembolism of viscera or extremities (diagnosed by acute symptoms and relevant diagnostic tests).

Classified as major or minor bleeding events.
Major: intracranial hemorrhage, fatal bleeding, bleeding resulting in hemoglobin loss equal to or greater than 2.0 g / L, hemorrhage requiring transfusion, bleeding in sensitive areas such as the retina or pericardium.
Minor: all other bleeding.

TTR calculated by Rosendaal Method also known as linear interpolation method. We will calculate the mean TTR for each formulation of warfarin; difference between the mean TTRs will be the outcome.
We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

trigonella/antimycoticum

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

Evaluation of Fenugreek Seed Extract In Type- 2 Diabetes: An Add-On Study

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

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