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

NCT01116310 | Unknown Phase 4

• 1 other identifier: LCF-GIN-2008-EC02
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 20

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.

Conditions

Postmenopausal Women With Moderate Vasomotor Symptoms

Keywords

Hot flushes; Hot flashes; menopause; postmenopause; Soy isoflavones; Red clover; Equol

Outcome Measures

Primary Outcomes (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).

  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

Secondary Outcomes (6)

• Intensity of Hot Flashes

  16 weeks

• Impact of the treatment with FITOGYN on the overall symptoms of menopause: fatigue, joint pain, vaginal dryness and sleep disturbances among others.

  16 weeks

• Effect of the treatment with FITOGYN in the level of anxiety of postmenopausal women.

  16 weeks

• Effect of the treatment with FITOGYN in the quality of life of postmenopausal women.

  16 weeks

• Evaluate the change in the subject's lipidic profile.

  16 weeks

Study Arms (2)

Fitogyn

EXPERIMENTAL

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); Drug: Placebo

Placebo

PLACEBO COMPARATOR

20 weeks with placebo, taking two capsules per day during the breakfast.

Drug: Placebo

Interventions

Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L) DRUG

Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones

Also known as: Fitogyn

Fitogyn

Placebo DRUG

Bottles containing 60 capsules.

Fitogyn; Placebo

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 who have given written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Casen-Fleet S.L.U.: lead
• Apices Soluciones S.L.: collaborator
• Asociacion Colaboracion Cochrane Iberoamericana: collaborator

Study Sites (20)

Hospital Central de Asturias

Asturias, H. Central de Asturias, Spain

WITHDRAWN

Hospital del Cruces

Barakaldo, 48903, Spain

RECRUITING

Assir CAP Sant Martí

Barcelona, 08020, Spain

WITHDRAWN

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

USP Instituto Universitario Dexeus

Barcelona, 08028, Spain

ACTIVE NOT RECRUITING

ASSIR CAP San Andreu

Barcelona, 08030, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

RECRUITING

Hospital Monteprincipe

Boadilla Del Monte, Madrid, 28660, Spain

RECRUITING

Hospital General de Ciudad Real

Ciudad Real, 13005, Spain

ACTIVE NOT RECRUITING

Centro Diatros

Gavá (Barcelona), 08850, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

RECRUITING

Consorci Sanitari d l´Anoia-H. de Igualada

Igualada, Barcelona, 08700, Spain

RECRUITING

Centro de Estudios de Obstetricia y Ginecología Asociado Lugo

Lugo, 27002, Spain

RECRUITING

Gabinete Médico Velázquez

Madrid, 28001, Spain

RECRUITING

Instituto Palacios

Madrid, 28009, Spain

RECRUITING

Hospital Mateu Orfila

Maó, 07701, Spain

WITHDRAWN

H. San Joan d'Alacant

San Juan, Alicante, 03550, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, 46009, Spain

RECRUITING

Hospital Doctor Pesset

Valencia, 46017, Spain

RECRUITING

Hospital Miguel Servet

Zaragoza, 50009, Spain

WITHDRAWN

MeSH Terms

Conditions

Hot Flashes

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Carlos J. Badiola, M.D.

CONTACT

+34 91 352 83 70; cjbadiola@casenfleet.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 28, 2011

Record last verified: 2011-09

Locations

ES (20)