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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Laboratorios Casen-Fleet S.L.U..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Apices Soluciones S.L.
Centro Cochrane Iberoamericano
Information provided by (Responsible Party):
Laboratorios Casen-Fleet S.L.U.
ClinicalTrials.gov Identifier:
NCT01116310
First received: May 3, 2010
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Postmenopausal Women With Moderate Vasomotor Symptoms
Drug: Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Laboratorios Casen-Fleet S.L.U.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Intensity of Hot Flashes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 166
Study Start Date: April 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116310

Contacts
Contact: Carlos J. Badiola, M.D. +34 91 352 83 70 cjbadiola@casenfleet.com

Locations
Spain
Hospital Central de Asturias Withdrawn
Asturias, Spain, H. Central de Asturias
Hospital del Cruces Recruiting
Barakaldo, Spain, 48903
Principal Investigator: José L. Neyro, Dr.         
Hospital Universitari Vall d'Hebrón Recruiting
Barcelona, Spain, 08035
Principal Investigator: Francesc Baró, Dr.         
Assir CAP Sant Martí Withdrawn
Barcelona, Spain, 08020
USP Instituto Universitario Dexeus Active, not recruiting
Barcelona, Spain, 08028
ASSIR CAP San Andreu Active, not recruiting
Barcelona, Spain, 08030
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Principal Investigator: Misericordia Guinot, 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.         
Instituto Palacios Recruiting
Madrid, Spain, 28009
Principal Investigator: Santiago Palacios, Dr.         
Gabinete Médico Velázquez Recruiting
Madrid, Spain, 28001
Principal Investigator: Silvia González, 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 Doctor Pesset Recruiting
Valencia, Spain, 46017
Principal Investigator: Antonio Cano, Dr.         
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46009
Principal Investigator: Dolores Juliá, Dr.         
Hospital Miguel Servet Withdrawn
Zaragoza, Spain, 50009
Sponsors and Collaborators
Laboratorios Casen-Fleet S.L.U.
Apices Soluciones S.L.
Centro Cochrane Iberoamericano
Investigators
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
  More Information

No publications provided

Responsible Party: Laboratorios Casen-Fleet S.L.U.
ClinicalTrials.gov Identifier: NCT01116310     History of Changes
Other Study ID Numbers: LCF-GIN-2008-EC02
Study First Received: May 3, 2010
Last Updated: September 27, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Casen-Fleet S.L.U.:
Hot flushes
Hot flashes
menopause
postmenopause
Soy isoflavones
Red clover
Equol

ClinicalTrials.gov processed this record on September 18, 2014