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

2014-08-27 03:16:07 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Menopause

Intervention

Femarelle, Placebo

Status

Not yet recruiting

Source

Se-cure Pharmaceuticals Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:07-0400

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The transitional period before and after MENOPAUSE. Perimenopausal symptoms are associated with irregular MENSTRUAL CYCLE and widely fluctuated hormone levels. They may appear 6 years before menopause and subside 2 to 5 years after menopause.

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The premature cessation of menses (MENSTRUATION) when the last menstrual period occurs in a woman under the age of 40. It is due to the depletion of OVARIAN FOLLICLES. Premature MENOPAUSE can be caused by diseases; OVARIECTOMY; RADIATION; chemicals; and chromosomal abnormalities.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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