4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast.

20 weeks with placebo, taking two capsules per day during the breakfast.

Postmenopausal Women With Moderate Vasomotor Symptoms

Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones

Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)

Placebo

Hospital Central de Asturias

Hospital del Cruces

Assir CAP Sant Martí

Hospital de la Santa Creu i Sant Pau

USP Instituto Universitario Dexeus

ASSIR CAP San Andreu

Hospital Universitari Vall d'Hebrón

Hospital Monteprincipe

Hospital General de Ciudad Real

Centro Diatros

Hospital Universitario de Guadalajara

Consorci Sanitari d l´Anoia-H. de Igualada

Centro de Estudios de Obstetricia y Ginecología Asociado Lugo

Gabinete Médico Velázquez

Instituto Palacios

Hospital Mateu Orfila

H. San Joan d'Alacant

Hospital Universitario La Fe

Hospital Doctor Pesset

Hospital Miguel Servet

Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause

Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Tolerability of the Combination of Soy Isoflavones and Red Clover Extract (FITOGYN) in the Treatment of the Hot Flushes in Menopausal Women.

This change will be expressed in absolute value and proportion of reduction with regard to the number basal of symptoms reported in the last week of the period of pre inclusion. The average or average of the reduction of hot flushes in every week of treatment and at the end of the treatment will be compared. This information will be obtained for every group and recorded by the women using a "hot flushes diary".
Additionally, the average change will be evaluated using the hot flash score (frequency combined with intensity) following the same methodology.

Intensity of the hot flushes that the participants communicate in the "hot flushes diary". The variable "intensity" of symptoms will be gathered in the categories of "mild", "moderate", "intense" and "very intense ", according to Sloan et al. J clin Oncol. 2001 dec 1;19 (23):4280-90 definitions.

The information about symptoms of the menopause will be gathered across Heinemann's Menopause Rating Scale (Self-administered instrument that evaluates 11 symptoms of menopause on a 5-point scale from 0, no symptom, to 4, extremely severe symptom. The total score includes 3 dimensions or factors: psychological, somato-vegetative, and urogenital. The overall score will be obtained for each domain and assessed at baseline and after 16 weeks of treatment.)

The anxiety subscale of the Hospital Anxiety-Depression Scale (HADS) will be used. HADS is a self-administered instrument comprised of 14 items (7 explore symptoms of depression and 7 others explore symptoms of anxiety). Each item is scored from 0 to 3 where 0 represents no symptom and 3 the most severe or frequent symptoms. Two scores are obtained by summing the 7 items of each sub-scale, depression and anxiety (HADS-D and HADS-A), with a score range for each from 0 to 21. The overall score will be obtained and for the anxiety domain assessed at baseline and after 16 weeks of treatment.

The Scale of Cervantes will be used to evaluate quality of life. It consists of 31 items that are distributed in the following dimensions:
Menopause and health (15 items assessing vasomotor symptoms, health and aging)
Sexuality (4 items)
Relationships (3 items)
Psychic domain (9 items) The overall score will be obtained and assessed for each domain at baseline and after 16 weeks of treatment.

The average difference in mm/dL between baseline and after 16 weeks of treatment will be determined.

The average difference between baseline and after 16 weeks of treatment in some haematological (Haemoglobin, WBC Differential Count and platelets), biochemistry (standard biochemistry witch include at least Lactate dehydrogenase, cholesterol, triglycerides and thyroid function) and urinalysis parameters will be determined.

equol/lodhja

Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause

Baza e të dhënave më e plotë e bimëve medicinale e mbështetur nga shkenca