NCT01063725

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

A Multi-center, Randomized, Placebo-controlled Double Blind Clinical Study Assessing the Efficacy and Safety of Femarelle® in Menopausal Women With Vasomotor Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Se-cure Pharmaceuticals Ltd. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Symptomatic menopausal women will be divided to treatment with Femarelle or placebo for 12 weeks after two weeks of baseline record. Hot flashes daily diary will be recorded daily and a quality of life questionnaire will be filled at the beginning and at completion of the study.

Conditions

• Menopause
• Hot Flashes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2010-02-05
• Last updated: 2011-10-12

Locations

5 sites across 1 country: Israel