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

NCT01116310 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2011-09-28

No results posted yet for this study

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

Interventions

DRUG

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

Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones

DRUG

Placebo

Bottles containing 60 capsules.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Asociacion Colaboracion Cochrane Iberoamericana

    collaborator OTHER

  • Laboratorios Casen-Fleet S.L.U.

    lead INDUSTRY

Principal Investigators

  • Joaquím Calaf, Dr. · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  • Cano Antonio, Dr. · Hospital Doctor Pesset

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116310 on ClinicalTrials.gov