Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause (TRYSEM)
|ClinicalTrials.gov Identifier: NCT01116310|
Recruitment Status : Unknown
Verified September 2011 by Laboratorios Casen-Fleet S.L.U..
Recruitment status was: Recruiting
First Posted : May 4, 2010
Last Update Posted : September 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Women With Moderate Vasomotor Symptoms||Drug: Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L) Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official 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.|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||July 2012|
4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast.
Drug: Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)
Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones
Other Name: FitogynDrug: Placebo
Bottles containing 60 capsules.
Placebo Comparator: Placebo
20 weeks with placebo, taking two capsules per day during the breakfast.
Bottles containing 60 capsules.
- 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). [ Time Frame: 16 weeks ]
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 Hot Flashes [ Time Frame: 16 weeks ]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.
- Impact of the treatment with FITOGYN on the overall symptoms of menopause: fatigue, joint pain, vaginal dryness and sleep disturbances among others. [ Time Frame: 16 weeks ]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.)
- Effect of the treatment with FITOGYN in the level of anxiety of postmenopausal women. [ Time Frame: 16 weeks ]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.
- Effect of the treatment with FITOGYN in the quality of life of postmenopausal women. [ Time Frame: 16 weeks ]
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.
- Evaluate the change in the subject's lipidic profile. [ Time Frame: 16 weeks ]The average difference in mm/dL between baseline and after 16 weeks of treatment will be determined.
- Evaluation of the safety and tolerability. [ Time Frame: 16 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116310
|Contact: Carlos J. Badiola, M.D.||+34 91 352 83 firstname.lastname@example.org|
|Hospital Central de Asturias||Withdrawn|
|Asturias, Spain, H. Central de Asturias|
|Hospital del Cruces||Recruiting|
|Barakaldo, Spain, 48903|
|Principal Investigator: José L. Neyro, Dr.|
|Assir CAP Sant Martí||Withdrawn|
|Barcelona, Spain, 08020|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Principal Investigator: Misericordia Guinot, Dr.|
|USP Instituto Universitario Dexeus||Active, not recruiting|
|Barcelona, Spain, 08028|
|ASSIR CAP San Andreu||Active, not recruiting|
|Barcelona, Spain, 08030|
|Hospital Universitari Vall d'Hebrón||Recruiting|
|Barcelona, Spain, 08035|
|Principal Investigator: Francesc Baró, Dr.|
|Boadilla del Monte, Madrid, Spain, 28660|
|Principal Investigator: Manuel Marcos, Dr.|
|Hospital General de Ciudad Real||Active, not recruiting|
|Ciudad Real, Spain, 13005|
|Gavá (Barcelona), Spain, 08850|
|Principal Investigator: Rafael Sánchez Borrego, Dr.|
|Hospital Universitario de Guadalajara||Recruiting|
|Guadalajara, Spain, 19002|
|Principal Investigator: María J. Cancelo, Dr.|
|Consorci Sanitari d l´Anoia-H. de Igualada||Recruiting|
|Igualada, Barcelona, Spain, 08700|
|Principal Investigator: Ana R Pérez Aguado, Dr.|
|Centro de Estudios de Obstetricia y Ginecología Asociado Lugo||Recruiting|
|Lugo, Spain, 27002|
|Principal Investigator: Francisco Vázquez, Dr.|
|Gabinete Médico Velázquez||Recruiting|
|Madrid, Spain, 28001|
|Principal Investigator: Silvia González, Dr.|
|Madrid, Spain, 28009|
|Principal Investigator: Santiago Palacios, Dr.|
|Hospital Mateu Orfila||Withdrawn|
|Mao, Spain, 07701|
|H. San Joan d'Alacant||Recruiting|
|San Juan, Alicante, Spain, 03550|
|Principal Investigator: Francisco Quereda, Dr.|
|Hospital Universitario La Fe||Recruiting|
|Valencia, Spain, 46009|
|Principal Investigator: Dolores Juliá, Dr.|
|Hospital Doctor Pesset||Recruiting|
|Valencia, Spain, 46017|
|Principal Investigator: Antonio Cano, Dr.|
|Hospital Miguel Servet||Withdrawn|
|Zaragoza, Spain, 50009|
|Study Chair:||Joaquím Calaf, Dr.||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|
|Study Chair:||Cano Antonio, Dr.||Hospital Doctor Pesset|