Trial Condition(s):

Vasomotor Symptoms, Hot Flashes

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

Bayer Identifier:

91493

ClinicalTrials.gov Identifier:

NCT00446199

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Inclusion Criteria
-  Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week
Exclusion Criteria
-  The usual exclusion criteria for hormone therapy apply
-  Intake of medications other than hormones affecting hot flushes

Trial Summary

Enrollment Goal
735
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Low-Dose E2/DRSP (BAY86-4891)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Eastern Virginia Medical School

Norfolk, United States, 23507

Status
Completed
 
Locations

University of Medicine and Dentistry of New Jersey

New Brunswick, United States, 08901

Status
Completed
 
Locations

Clinical Trials Research Services, LLC

Pittsburgh, United States, 15206

Status
Completed
 
Locations

Women's Health Care Specialist

Paw Paw, United States, 49079

Status
Completed
 
Locations

Planned Parenthood of Houston and SE Texas

Houston, United States, 77004

Status
Completed
 
Locations

Blue Skies Center for Women

Colorado Springs, United States, 80910

Status
Completed
 
Locations

OB-GYN Centre of Excellence

Chattanooga, United States, 37404

Status
Completed
 
Locations

Hawthorne Medical Research, Inc.

Winston-Salem, United States, 27103

Status
Completed
 
Locations

The Medical Group of Northern Nevada

Reno, United States, 89502

Status
Completed
 
Locations

Princeton Genetics Research, LLC

Princeton, United States, 08540

Status
Completed
 
Locations

Fletcher Allen Health Care

Burlington, United States, 05401

Status
Completed
 
Locations

Women's Clinical Research Center DBA Seattle Women's Health

Seattle, United States, 98105

Status
Completed
 
Locations

The Hospital of Central Connecticut

New Britain, United States, 06050

Status
Completed
 
Locations

Planned Parenthood of Arkansas and Eastern Oklahoma

Tulsa, United States, 74105

Status
Completed
 
Locations

Southeastern Clinical Research

Chattanooga, United States, 37403

Status
Completed
 
Locations

York Clinical Consulting

Marrero, United States, 70072

Status
Completed
 
Locations

Elite Research Institute

Miami, United States, 33169

Status
Completed
 
Locations

Advanced Clinical Therapeutics

Tucson, United States, 85712

Status
Completed
 
Locations

Advanced Research Institute

New Port Richey, United States, 34655

Status
Completed
 
Locations

Advances in Health, inc.

Houston, United States, 77030

Status
Completed
 
Locations

Columbus Center for Women's Health Research

Columbus, United States, 43213

Status
Completed
 
Locations

Valley Women's Clinic

Renton, United States, 98055

Status
Completed
 
Locations

Infertility, Gynecology & Obstetrics Med. Group

San Diego, United States, 92121

Status
Completed
 
Locations

Research Across America

Dallas, United States, 75234

Status
Completed
 
Locations

Women's Clinic of Lincoln, PC

Lincoln, United States, 68510

Status
Completed
 
Locations

Today's Women's Health

Chandler, United States, 85225

Status
Completed
 
Locations

Genova Clinical Research Inc

Tucson, United States, 85741

Status
Completed
 
Locations

Insignia Clinical Research

Tampa, United States, 33607

Status
Completed
 
Locations

Research Associates

Boise, United States, 83702

Status
Completed
 
Locations

York Clinical Consulting

Amite, United States, 70422

Status
Completed
 
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
 
Locations

Cetero Research

Fargo, United States, 58105

Status
Completed
 
Locations

Comprehensive Clinical Trials

West Palm Beach, United States, 33409

Status
Completed
 
Locations

Visions Clinical Research

Boynton Beach, United States, 33437

Status
Completed
 
Locations

Rosemark Women Care Specialist

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Rapid Medical Research Inc.

Cleveland, United States, 44122

Status
Completed
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

WomanCare

Arlington Heights, United States, 60004

Status
Completed
 
Locations

Avera Research Institute

Sioux Falls, United States, 57105

Status
Completed
 
Locations

New Age Medical Research Corp.

Miami, United States, 33186

Status
Completed
 
Locations

Visions Clinical Research - Tucson

Tucson, United States, 85712

Status
Completed
 
Locations

University of Florida Women's Health- Specialists Emerson

Jacksonville, United States, 32216

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

South Carolina Clinical Research Center

Columbia, United States, 29201

Status
Completed
 
Locations

Ridgeview Research

Chaska, United States, 55318

Status
Completed
 
Locations

Clinical Physiology Associates, Inc.

Fort Myers, United States, 33916

Status
Completed
 
Locations

The Women's Specialist of Houston

Houston, United States, 77030

Status
Completed
 
Locations

University of Kentucky

Lexington, United States, 40536

Status
Completed
 
Locations

Adam Patterson OB-GYN

Memphis, United States, 38120

Status
Completed
 
Locations

National Clinical Research, Inc.

Richmond, United States, 23294

Status
Completed
 
Locations

Office of Dr. Alfred Moffett, MD

Leesburg, United States, 34748

Status
Completed
 
Locations

Coastal Clinical Research, Inc

Mobile, United States, 36608

Status
Completed
 
Locations

Bayview Research Group, LLC

Paramount, United States, 90723

Status
Completed
 
Locations

Mount Vernon Clinical Research

Atlanta, United States, 30328

Status
Completed
 
Locations

Montana Health Research Institute

Billings, United States, 59102

Status
Completed
 
Locations

Bio-Kinetic Clinical Applications

Springfield, United States, 65802

Status
Completed
 
Locations

Bayview Research Group, LLC

Valley Village, United States, 91607

Status
Completed
 
Locations

North Coast Women's Care, Inc

Vista, United States, 92083

Status
Completed
 
Locations

Soapstone Center for Clinical Research

Decatur, United States, 30034

Status
Completed
 
Locations

Women's Health Care, Inc.

San Diego, United States, 92123

Status
Completed
 
Locations

Tampa Bay Medical Research, Inc.

Clearwater, United States, 33761

Status
Completed
 
Locations

Clinical Research Center of Nevada

Las Vegas, United States, 89104

Status
Completed
 
Locations

OB/GYN Associates of Erie

Erie, United States, 16502

Status
Completed
 
Locations

Lyndhurst Gynecologic Associates

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Atlantic Institute of Clinical Research

Daytona Beach, United States, 32114

Status
Completed
 
Locations

Downtown Women's Healthcare

Denver, United States, 80218

Status
Completed
 
Locations

Loyola University Health System - LaGrange Park

La Grange Park, United States, 60526

Status
Completed
 
Locations

Wake Research Asssociates

Raleigh, United States, 27612

Status
Completed
 
Locations

Southwest Clinical Research

Albuquerque, United States, 87102

Status
Completed
 
Locations

Wellborn Clinic Newburgh

Newburgh, United States, 47630

Status
Completed
 
Locations

Women's Health Practice

Champaign, United States, 61820

Status
Completed
 
Locations

Altus Research

Lake Worth, United States, 33461

Status
Completed
 
Locations

Dr. Susan Floyd, MD

Wexford, United States, 15090

Status
Completed
 
Locations

COR Clinical Research, LLC

Oklahoma City, United States, 73103

Status
Completed
 
Locations

Estrella Womens Health Center

Phoenix, United States, 85031

Status
Completed
 
Locations

Altanta Women's Research Institute, Inc.

Atlanta, United States, 30342

Status
Completed
 
Locations

Billings Clinic Research Center

Billings, United States, 59101

Status
Completed
 
Locations

The Woman's Clinic, P.A.

Little Rock, United States, 72205

Status
Completed
 
Locations

Women's Health Research Center, LLC

Lawrenceville, United States, 08648

Status
Completed
 

Trial Design