Postmenopausal Women With Moderate Vasomotor Symptoms Clinical Trial
— TRYSEMOfficial title:
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.
The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause.
| Status | Recruiting |
| Enrollment | 166 |
| Est. completion date | July 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Women between 45 and 60 years of age. - Women in, the immediate or established postmenopausal phase, defined as women with: a) 12 months or more spontaneous amenorrhea or b) 6 months or more spontaneous amenorrhea with levels of follicular stimulating hormone (FSH) above 40 mIU / ml. - Women with between 35 and 70 episodes of hot flashes (9 or more hot flashes should be of at least moderate intensity) in the week prior to the pre-inclusion period with placebo - Women who have given written informed consent. Exclusion Criteria: - Women with surgical menopause. - Treatment with HRT within 6 months of the screening visit. - Patients who needs oncological or immunosuppressive treatment during the expected follow-up period. - Patient with difficult follow-up or with psycho-neurological problems that hinder proper assessment (alcoholism, depression not caused by menopause, etc.) - Patients who, at the discretion of the investigator, can not be evaluated according to criteria established in this protocol - Patients following a vegetarian diet - Patients with any relevant gastrointestinal disease - Patients with a prior diagnosis of hypothyroidism or other clinically relevant thyroid disorder. - Patients treated and / or diagnosed or with suspicion of cancer. - Patients with diabetes mellitus who require insulin therapy. - Patients with current diagnosis of an affective disorder (e.g. depression), anxiety disorder, or psychotic disorder. - Patients with an organic mental disorder - Patients with neuropathic pain or any other form of pain that receive or need treatment with antidepressives or anticonvulsivants. - Patients receiving or requiring treatment with antidepressives or anticonvulsivants for other motives (for example, prevention of the migraine). - Patients consuming more than 2 alcoholic drinks (16-20 gr.) per day - Patients who have been treated with antibiotics within 3 months of the screening visit. - Patients receiving or requiring treatment with clonidine or vitamin E. - Patients who are treated with NSAIDs - Patients allergic to any of the components of FITOGYN - Patients who took less than 80% of the capsules in the pre-inclusion period with placebo. - Patients whose weekly number of hot flushes is reduced by 25% or more during the pre-inclusion period as compared to the week prior to the initiation of that period. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Central de Asturias | Asturias | |
| Spain | Hospital del Cruces | Barakaldo | |
| Spain | ASSIR CAP San Andreu | Barcelona | |
| Spain | Assir CAP Sant Martí | Barcelona | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebrón | Barcelona | |
| Spain | USP Instituto Universitario Dexeus | Barcelona | |
| Spain | Hospital Monteprincipe | Boadilla del Monte, Madrid | |
| Spain | Hospital General de Ciudad Real | Ciudad Real | |
| Spain | Centro Diatros | Gavá (Barcelona) | |
| Spain | Hospital Universitario de Guadalajara | Guadalajara | |
| Spain | Consorci Sanitari d l´Anoia-H. de Igualada | Igualada, Barcelona | |
| Spain | Centro de Estudios de Obstetricia y Ginecología Asociado Lugo | Lugo | |
| Spain | Gabinete Médico Velázquez | Madrid | |
| Spain | Instituto Palacios | Madrid | |
| Spain | Hospital Mateu Orfila | Mao | |
| Spain | H. San Joan d'Alacant | San Juan, Alicante | |
| Spain | Hospital Doctor Pesset | Valencia | |
| Spain | Hospital Universitario La Fe | Valencia | |
| Spain | Hospital Miguel Servet | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratorios Casen-Fleet S.L.U. | Apices Soluciones S.L., Asociacion Colaboracion Cochrane Iberoamericana |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change in the number of symptoms of hot flashes (including night sweats) at the end of the study (week 22) with respect to baseline (week 6). | 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. |
16 weeks | No |
| Secondary | Intensity of Hot Flashes | 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. | 16 weeks | No |
| Secondary | Impact of the treatment with FITOGYN on the overall symptoms of menopause: fatigue, joint pain, vaginal dryness and sleep disturbances among others. | 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.) | 16 weeks | No |
| Secondary | Effect of the treatment with FITOGYN in the level of anxiety of postmenopausal women. | 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. | 16 weeks | No |
| Secondary | Effect of the treatment with FITOGYN in the quality of life of postmenopausal women. | 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. |
16 weeks | No |
| Secondary | Evaluate the change in the subject's lipidic profile. | The average difference in mm/dL between baseline and after 16 weeks of treatment will be determined. | 16 weeks | No |
| Secondary | Evaluation of the safety and tolerability. | 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. | 16 weeks | Yes |