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

Tracking Information

First Received Date ^ICMJE

July 15, 2005

Last Updated Date

June 14, 2007

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence and severity of hot flushes
Safety

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00122200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hot Flashes

Intervention ^ICMJE

Drug: Topical estradiol

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00122200

Responsible Party

Study ID Numbers ^ICMJE

EST-01

Study Sponsor ^ICMJE

VIVUS, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sam Teichman, MD

Vivus Clinical Research Department

Information Provided By

VIVUS, Inc.

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP