24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms

PHASE3CompletedINTERVENTIONAL
Enrollment

570

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

November 30, 2011

Conditions
Hot Flashes
Interventions
DRUG

Brisdelle (paroxetine mesylate)

Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

DRUG

Placebo capsules

Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

Trial Locations (32)

14609

Rochester Clinical Research, Rochester

15206

Clinical Trials Research Services, LLC, Pittsburgh

19046

The Clinical Trial Center, LLC, Jenkintown

19114

Philadelphia Clinical Research, Philadelphia

23233

Virginia Women's Center, Richmond

23294

National Clinical Research, Inc., Richmond

27103

Hawthorne Medical Research, Inc., Winston-Salem

27408

Hawthorne Research, Greensboro

29201

SC Clinical Research Center, LLC, Columbia

29464

Coastal Carolina Research Center, Mt. Pleasant

30034

Soapstone Center for Clinical Research, Decatur

30328

Mount Vernon Clinical Research, LLC, Sandy Springs

33409

Comprehensive Clinical Trials, LLC, West Palm Beach

33461

Altus Research, Lake Worth

33472

Visions Clinical Research, Boynton Beach

33759

Women's Medical Research Group, LLC, Clearwater

34102

Anchor Research Center, Naples

34601

Meridien Research, Brooksville

36116

Montgomery Women's Health Associates, PC, Montgomery

37203

Clinical Research Associates, Inc., Nashville

37404

Chattanooga Medical Research, LLC, Chattanooga

43213

Columbus Center for Women's Health Research, Columbus

68510

Women's Clinic of Lincoln, PC, Lincoln

77054

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

80218

Downtown Women's Health Care, Denver

85224

East Valley Family Physicians PLC, Chandler

92103

Genesis Center For Clinical Research, San Diego

92705

Apex Research Institute, Santa Ana

98105

Women's Clinical Research Center, Seattle

99207

North Spokane Women's Clinic Research, Spokane

06708

Chase Medical Research, LLC, Waterbury

08057

Phoenix Ob-Gyn Associates, LLC, Moorestown

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Noven Therapeutics

INDUSTRY