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Clinical Trial Summary

The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone combination in relieving the symptoms associated with Climacteric Syndrome.


Clinical Trial Description

It is known that Hormone Therapy is recommended postmenopausal women to reduce menopausal symptoms and prevent osteoporosis frames and cardiovascular disease. However, only 30 to 40% of women still using hormone therapy.

One reason women do not continue or are reluctant to start Hormone Therapy is realizing that the prescription of hormones is not a natural situation. Therefore, there is an increased interest in the use and prescription of estrogen derived from plants, known as fitoestrogênios.

The development of a drug containing two standardized extracts was focused on two main symptoms of menopause: hot flashes and anxiety. This product comes from a longing for the doctors themselves can respond more promptly to patients who reach menopause and who already has a framework for mild to moderate anxiety.

Thus, to meet the woman who develops menopausal symptoms and that these two are highly prevalent during menopause, causing intense discomfort routine for this woman, was produced in association with Soy Passiflora aiming to control anxiety and hot flushes ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01695616
Study type Interventional
Source Ache Laboratorios Farmaceuticos S.A.
Contact
Status Withdrawn
Phase Phase 3
Start date August 2013
Completion date March 2015

See also
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Completed NCT03118908 - Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome N/A