Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)

PHASE3CompletedINTERVENTIONAL
Enrollment

614

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

December 31, 2011

Study Completion Date

February 29, 2012

Conditions
Postmenopausal Symptoms
Interventions
DRUG

Brisdelle (paroxetine mesylate)

Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

DRUG

Placebo capsules

Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Trial Locations (74)

10038

NY Center for Women's Health Research, New York

15090

Susan L Floyd, MD, PC, Wexford

15206

Clinical Trials Research Services, LLC, Pittsburgh

19046

The Clinical Trial Center, LLC, Jenkintown

19114

Philadelphia Clinical Research, Philadelphia

20036

James A. Simon, MD, PC, Washington D.C.

23233

Virginia Women's Center, Richmond

23294

National Clinical Research, Inc., Richmond

23456

Tidewater Clinical Research, Inc, Virginia Beach

27103

Clinical Trials of America, Inc., Winston-Salem

Hawthorne Medical Research, Inc., Winston-Salem

27612

Wake Research Associates, Raleigh

29464

Coastal Carolina Research Center, Mt. Pleasant

30034

Soapstone Center for Clinical Research, Decatur

30328

Mount Vernon Clinical Research, LLC, Sandy Springs

32207

University of Florida College of Medicine - Jacksonville Southside Women's Health, Jacksonville

33441

DBC Research, Deerfield Beach

33458

Health Awareness, Inc., Jupiter

33761

Tampa Bay Medical Research, Inc., Clearwater

33916

Clinical Physiology Associates, Fort Myers

34208

Meridien Research, Bradenton

34601

Meridien Research, Brooksville

34652

Suncoast Clinical Research, Inc., New Port Richey

34684

Suncoast Clinical Research, Inc., Palm Harbor

36608

Wilmax Clinical Research, Mobile

37043

Access Clinical Trials, Inc., Nashville

37404

Chattanooga Medical Research, LLC, Chattanooga

40291

Bluegrass Clinical Research, Inc., Louisville

43213

Columbus Center for Women's Health Research, Columbus

43231

Complete Healthcare for Women, Columbus

44122

Rapid Medical Research, Inc., Cleveland

44124

University Hospitals of Cleveland Landerbrook Health Center, Mayfield Heights

45424

HWC Women's Research Center, Englewood

48106

ClinSite, LLC, Ann Arbor

48201

Hutzel Womens Health Research, Detroit

49616

Professional Clinical Research, Benzonia

49643

Professional Clinical Research, Interlochen

60004

Affinity Healthcare, Arlington Heights

68510

Women's Clinic of Lincoln, PC, Lincoln

72401

NEA Baptist Women's Clinic, Jonesboro

73112

Sooner Clinical Research, Inc., Oklahoma City

77030

Advances In Health, Inc., Houston

77054

The Woman's Hospital of Texas Clinical Research Center, Houston

77450

Research Across America, Katy

77802

DiscoveResearch, Inc., Bryan

78229

Clinical Trials of Texas, Inc., San Antonio

Radiant Research, Inc., San Antonio

78745

Tekton Research, Austin

80218

Downtown Women's Health Care, Denver

80220

Horizons Clinical Research Center, LLC, Denver

80524

The Women's Clinic of Northern Colorado, Fort Collins

83642

Advanced Clinical Research, Boise

85224

East Valley Family Physicians PLC, Chandler

85308

Advanced Research Associates, Glendale

85381

Premier Research Group Limited, Peoria

85710

Verona Clinical Research, Inc, Tucson

87102

Albuquerque Clinical Trials, Albuquerque

87106

New Mexico Clinical Research & Osteoporosis Center, Inc., Albuquerque

89104

Clinical Research Center of Nevada, Las Vegas

91345

Facey Medical Foundation, Mission Hills

91942

Grossmont Center for Clinical Research, La Mesa

92103

University Clinical Research, San Diego

92108

Medical Center for Clinical Research, San Diego

92705

Apex Research Institute, Santa Ana

93534

High Desert Medical Group, Lancaster

95821

Northern California Research, Sacramento

98105

Women's Clinical Research Center, Seattle

99207

North Spokane Women's Clinic Research, Spokane

06810

Danbury Clinical Research, LLC, Danbury

06320

Coastal Connecticut Research, LLC, New London

02301

Beacon Clinical Research, LLC, Brockton

02459

Neurocare Center for Research, Newton

08648

Lawrence Ob-Gyn Assoc., PC, Lawrenceville

02864

Partners in Clinical Research, Cumberland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Noven Therapeutics

INDUSTRY