Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause
NCT ID: NCT01116310
Last Updated: 2011-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
166 participants
INTERVENTIONAL
2010-04-30
2012-07-31
Brief Summary
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Detailed Description
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The duration of the study participants will be 22 weeks. 7 visits are planned during the study:
After the screening visit (visit 1), women selected will report on the daily occurrence of hot flushes for 2 weeks without treatment. If they experience the required number of hot flushes (35-70 hot flushes in the prior week and 9 or more of them with at least moderate intensity), a 4-week placebo run-in period will start (visit 2). After this time (Visit 3), women with a decrease lower than 25% in the number of hot flushes and a treatment adherence of at least 80% will be randomised to receive treatment (Fitogyn vs placebo) for 16 weeks.
During visit 3, baseline assessments of primary and secondary variables will be carried out. Additionally, blood and urine samples will be obtained to conduct hematological and biochemical tests, and assess thyroid function and lipid profile. In addition, patients will complete the following scales: "Menopausal Rating Scale (MRS)", the scales of anxiety (HADS) and quality of life (Scale of Cervantes).
Visits 4, 5 and 6: To assess every 4 weeks the treatment adherence, to do a safety evaluation and daily collection of hot flashes.
Visit 7: End of study (week 22 of study). During this visit the same activities described for visit 3 will be performed.
SUBSTUDY:
TITLE: "Evaluating the impact of the combination of soy isoflavones and red clover extract (FITOGYN) compared to placebo on some markers of atherogenesis"
The substudy will be conducted in a subsample of approximately 90 patients and will involve those Investigational Sites willing to conduct the substudy, given that they have the means for the proper and correct handling of samples. This study has an exploratory purpose, and will provide useful insight into the specific mechanisms of action of phytoestrogens as well as generate new hypotheses that can guide future research on this product. Additionally, blood equol levels will be measured to study their potential effect on treatment outcome with these isoflavones.
A number of biological parameters have been identified that are clearly related to the process of atherogenesis. This measurement would be from blood collections performed at baseline and the end of the trial, so that new blood collections will not be necessary beyond those already planned.
The selected parameters are:
1. Level of insulin resistance from HOMA.
2. Low density lipoprotein (LDL), oxidized (ox LDL) concentration.
3. Asymmetric dimethyl arginine concentration in endothelial cell culture
4. Measure the ratio of prostacyclin / thromboxane in urine.
5. Genesis of tissue factor in the endothelium.
6. Measurement of blood levels of equol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fitogyn
4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast.
Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)
Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones
Placebo
Bottles containing 60 capsules.
Placebo
20 weeks with placebo, taking two capsules per day during the breakfast.
Placebo
Bottles containing 60 capsules.
Interventions
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Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)
Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones
Placebo
Bottles containing 60 capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
60 Years
FEMALE
No
Sponsors
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Apices Soluciones S.L.
INDUSTRY
Asociacion Colaboracion Cochrane Iberoamericana
OTHER
Laboratorios Casen-Fleet S.L.U.
INDUSTRY
Responsible Party
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Principal Investigators
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Joaquím Calaf, Dr.
Role: STUDY_CHAIR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Cano Antonio, Dr.
Role: STUDY_CHAIR
Hospital Doctor Pesset
Locations
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Hospital Central de Asturias
Asturias, , Spain
Hospital del Cruces
Barakaldo, , Spain
Assir CAP Sant Martí
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
USP Instituto Universitario Dexeus
Barcelona, , Spain
ASSIR CAP San Andreu
Barcelona, , Spain
Hospital Universitari Vall d'Hebrón
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
Mahon, , Spain
H. San Joan d'Alacant
San Juan, Alicante, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Doctor Pesset
Valencia, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Other Identifiers
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LCF-GIN-2008-EC02
Identifier Type: -
Identifier Source: org_study_id