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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Apices Soluciones S.L.
Asociacion Colaboracion Cochrane Iberoamericana
Information provided by (Responsible Party):
Laboratorios Casen-Fleet S.L.U.

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Fitogyn
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: Fitogyn

Drug: Placebo
Bottles containing 60 capsules.

Placebo Comparator: Placebo
20 weeks with placebo, taking two capsules per day during the breakfast.
Drug: Placebo
Bottles containing 60 capsules.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01116310

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Contact: Carlos J. Badiola, M.D. +34 91 352 83 70

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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.         
Hospital Monteprincipe Recruiting
Boadilla del Monte, Madrid, Spain, 28660
Principal Investigator: Manuel Marcos, Dr.         
Hospital General de Ciudad Real Active, not recruiting
Ciudad Real, Spain, 13005
Centro Diatros Recruiting
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.         
Instituto Palacios Recruiting
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
Sponsors and Collaborators
Laboratorios Casen-Fleet S.L.U.
Apices Soluciones S.L.
Asociacion Colaboracion Cochrane Iberoamericana
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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

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Responsible Party: Laboratorios Casen-Fleet S.L.U. Identifier: NCT01116310     History of Changes
Other Study ID Numbers: LCF-GIN-2008-EC02
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011
Keywords provided by Laboratorios Casen-Fleet S.L.U.:
Hot flushes
Hot flashes
Soy isoflavones
Red clover
Additional relevant MeSH terms:
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Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs