Trial Condition(s):

Hot Flashes

Efficacy and Safety study in postmenopausal women to determine the lowest effective dose for relief of moderate to severe hot-flushes

Bayer Identifier:

91429

ClinicalTrials.gov Identifier:

NCT00206622

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women

Inclusion Criteria
- Menopause- Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
Exclusion Criteria
- Hormonal treatment- Contraindication to estrogen/progestogen therapy

Trial Summary

Enrollment Goal
425
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Climara PRO (E2/LNG)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Comprehensive Clinical Trials

West Palm Beach, United States, 33409

Status
Completed
 
Locations

St. Louis University Hospital

St. Louis, United States, 63110

Status
Completed
 
Locations

University of Medicine and Dentistry of New Jersey

New Brunswick, United States, 08901

Status
Completed
 
Locations

Rosemark Women Care Specialist

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Northern Indiana Womens Heatlh Research, Inc.

South Bend, United States, 46601

Status
Completed
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

Planned Parenthood of Houston and SE Texas

Houston, United States, 77004

Status
Completed
 
Locations

Estrella Womens Health Center

Phoenix, United States, 85031

Status
Completed
 
Locations

Southwest Clinical Research

Albuquerque, United States, 87102

Status
Completed
 
Locations

Radiant Research - San Diego

San Diego, United States, 92108

Status
Completed
 
Locations

Visions Clinical Research - Tucson

Tucson, United States, 85712

Status
Completed
 
Locations

Wayne State University

Detroit, United States, 48201

Status
Completed
 
Locations

University of Florida-Gainesville

Gainesville, United States, 32610-0254

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Jean Brown Research

Salt Lake City, United States, 84124

Status
Completed
 
Locations

Clinical Trials Research Services, LLC

Pittsburgh, United States, 15206

Status
Completed
 
Locations

Greater Hartford Women's Health Assoc.

West Hartford, United States, 06117

Status
Completed
 
Locations

Women's Health Care, Inc.

San Diego, United States, 92123

Status
Completed
 
Locations

Falcon Center for Women

Peoria, United States, 61615

Status
Completed
 
Locations

The Medical Group of Northern Nevada

Reno, United States, 89502

Status
Completed
 
Locations

Fletcher Allen Health Care

Burlington, United States, 05401-1420

Status
Completed
 
Locations

Jacksonville Center for Clinical Research

Jacksonville, United States, 32216

Status
Completed
 
Locations

Medical Center of North Texas

Arlington, United States, 76012

Status
Completed
 
Locations

King's Daughters Hospital

Temple, United States, 76502-1896

Status
Completed
 
Locations

Women's Center for Clinical Research

New Orleans, United States, 70115

Status
Completed
 
Locations

University of Kentucky

Lexington, United States, 40536

Status
Completed
 
Locations

York Clinical Consulting

New Orleans, United States, 70118-1034

Status
Completed
 
Locations

Radiant Research - Cincinnati

Cincinnati, United States, 45236

Status
Completed
 
Locations

The Hospital of Central Connecticut

New Britain, United States, 06050

Status
Completed
 
Locations

Atlanta Women's Research Institute, Inc.

Alpharetta, United States, 30005

Status
Completed
 
Locations

Advanced Clinical Therapeutics

Tucson, United States, 85712

Status
Completed
 
Locations

Columbus Center for Women's Health Research

Columbus, United States, 43213

Status
Completed
 
Locations

Philadelphia Clinical Research

Philadelphia, United States, 19114

Status
Completed
 
Locations

Center for Women's Research

Chicago, United States, 60612

Status
Completed
 
Locations

Stedman Clinical Trials

Tampa, United States, 33613

Status
Completed
 
Locations

Adam Patterson OB-GYN

Memphis, United States, 38120

Status
Completed
 
Locations

Women's Health Practice

Champaign, United States, 61820

Status
Completed
 
Locations

Medical Affiliated Research Center

Huntsville, United States, 35801

Status
Completed
 
Locations

Advances in Health, inc.

Houston, United States, 77030

Status
Completed
 
Locations

Lyndhurst Gynecologic Associates

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Women's Clinic of Lincoln, PC

Lincoln, United States, 68510

Status
Completed
 
Locations

Rapid Medical Research Inc.

Cleveland, United States, 44122

Status
Completed
 
Locations

Today's Women's Health

Chandler, United States, 85225

Status
Completed
 
Locations

Research Associates

Boise, United States, 83702

Status
Completed
 
Locations

Clinical Study Center

Fort Myers, United States, 33916

Status
Completed
 
Locations

Douglas Young, MD

Fair Oaks, United States, 95628

Status
Completed
 
Locations

Foundation for Osteoporsis Research and Education

Oakland, United States, 94612

Status
Completed
 

Trial Design