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

This study has been completed.

First Received: July 15, 2005 Last Updated: June 14, 2007 History of Changes

Sponsor:	VIVUS, Inc.
Information provided by:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00122200

Purpose

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.

Condition	Intervention	Phase
Hot Flashes	Drug: Topical estradiol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

Incidence and severity of hot flushes
Safety

Estimated Enrollment:	450
Study Start Date:	December 2004
Study Completion Date:	November 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women
Ages 35 or older
Frequent moderate to severe hot flushes
Qualifying general medical health

Exclusion Criteria:

Disqualifying gynecological disorders
Disqualifying dermatological disorders
Disqualifying concurrent conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122200

Locations

United States, Virginia
University of Eastern Virginia
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

VIVUS, Inc.

Investigators

Study Director:

Sam Teichman, MD

Vivus Clinical Research Department

More Information

Additional Information:

prequalification questionnaire for patients This link exits the ClinicalTrials.gov site

No publications provided by VIVUS, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51.

Study ID Numbers:	EST-01
Study First Received:	July 15, 2005
Last Updated:	June 14, 2007
ClinicalTrials.gov Identifier:	NCT00122200 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Postmenopause

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hot Flashes
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents

Estradiol 17 beta-cypionate
Hormones
Estradiol
Pharmacologic Actions
Signs and Symptoms
Therapeutic Uses
Estradiol 3-benzoate
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 22, 2009