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Multi-Center Study to Evaluate Estradiol Transdermal Spray in the Treatment of Symptomatic Postmenopausal Women

2014-07-23 21:51:12 | BioPortfolio

Summary

Estradiol treatment is effective at reducing vasomotor symptoms (eg, hot flushes) in postmenopausal women. Vivus has a proprietary spray delivery system (Evamist) for estradiol. This study will evaluate the safety and efficacy of this product.

Description

This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by spray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Hot Flashes

Intervention

Topical estradiol

Location

University of Eastern Virginia
Norfolk
Virginia
United States
23507

Status

Completed

Source

VIVUS, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:51:12-0400

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Steroidal compounds related to ESTRADIOL, the major mammalian female sex hormone. Estradiol congeners include important estradiol precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with estrogenic activities.

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Cytoplasmic proteins that bind estradiol, migrate to the nucleus, and regulate DNA transcription.

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