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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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Medical and Biotech [MESH] Definitions

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.

A progesterone that has been used in ESTRUS SYNCHRONIZATION and has been evaluated as an injectable contraceptive in combination with estradiol enanthate. It is also used therapeutically as a topical anti-inflammatory and is applied topically in the treatment of ACNE.

Compounds which inhibit or antagonize the biosynthesis or action of estradiol.

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

Generally refers to the 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the PLACENTA. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of estradiol binds weakly to estrogen receptors (RECEPTORS, ESTROGEN) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.

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