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A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms

NCT01063725 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-10-12

No results posted yet for this study

Summary

The purpose of this study is to test the effects of Femarelle ( a plan-derived SERM) on hot flushes and quality of life in menopausal women. Our hypotheses are that compared to placebo, Femarelle reduces the daily number of hot flushes and their severity and also improves the quality of life as measured by validated dairies and questionnaires.

Conditions

Interventions

DIETARY_SUPPLEMENT

Femarelle

A soy based food supplement containing 322 mg of soy extract and 108 mg of flaxseed, to be taken twice daily

OTHER

Placebo

Capsules containing 430 mg of microcrystalline cellulose, as a placebo, to be taken twice daily

Sponsors & Collaborators

  • Clalit Health Services

    collaborator OTHER

  • Se-cure Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Bari Kaplan, Prof. · Clalit Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-10-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT01063725 on ClinicalTrials.gov