Low-Dose Hormone Therapy for Relief of Vasomotor Symptoms - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00446199

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.

Condition	Intervention	Phase
Vasomotor Symptoms Hot Flashes	Drug: SH T546P Drug: SH T04739CA and SH T04739BA Drug: SH T04739DA	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol 1,2-Dihydrospirorenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Mean change from baseline to Week 12 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change from baseline to Week 12 in vaginal pH and vaginal maturation index [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Symptoms of vulvar and vaginal atrophy and urogenital symptoms at baseline and Week 12 [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Enrollment:	910
Study Start Date:	March 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Placebo Comparator	Drug: SH T546P Matching placebo tablet
Arm 2: Experimental	Drug: SH T04739CA and SH T04739BA Drospirenone/E2- Both make up the Active Study Medication Tablet which is Drospirenone/17B-estradiol
Arm 3: Experimental	Drug: SH T04739CA and SH T04739BA Drospirenone/E2- Both make up the Active Study Medication Tablet which is Drospirenone/17B-estradiol
Arm 4: Experimental	Drug: SH T04739DA 17B-estradiol - Active Study Medication Tablet

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446199

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Locations

United States, Alabama

Mobile, Alabama, United States, 36608
United States, Arizona

Tucson, Arizona, United States, 85712

Chandler, Arizona, United States, 85225

Tucson, Arizona, United States, 85741

Phoenix, Arizona, United States, 85031
United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, California

San Diego, California, United States, 92103

San Diego, California, United States, 92108

San Diego, California, United States, 92123

San Diego, California, United States, 92121

Studio City, California, United States, 91604

Valley Village, California, United States, 91607

Vista, California, United States, 92083
United States, Colorado

Colorado Springs, Colorado, United States, 80910

Denver, Colorado, United States, 80202
United States, Connecticut

New Britain, Connecticut, United States, 06050
United States, Florida

West Palm Beach, Florida, United States, 33409

Boynton Beach, Florida, United States, 33437

Miami, Florida, United States, 33186

Jacksonville, Florida, United States, 32216

Miami, Florida, United States, 33169

New Port Richey, Florida, United States, 34655

Clearwater, Florida, United States, 33761

Lake Worth, Florida, United States, 33461

Tampa, Florida, United States, 33607

Fort Myers, Florida, United States, 33916

Leesburg, Florida, United States, 34748

Daytona Beach, Florida, United States, 32114
United States, Georgia

Atlanta, Georgia, United States, 30328

Atlanta, Georgia, United States, 30342

Decatur, Georgia, United States, 30034
United States, Idaho

Idaho Falls, Idaho, United States, 83404

Boise, Idaho, United States, 83702
United States, Illinois

Arlington Heights, Illinois, United States, 60004

La Grange Park, Illinois, United States, 60526

Champaign, Illinois, United States, 61820
United States, Indiana

Newburgh, Indiana, United States, 47630
United States, Kentucky

Lexington, Kentucky, United States, 40536
United States, Louisiana

Marrero, Louisiana, United States, 70072
United States, Michigan

Paw Paw, Michigan, United States, 49079
United States, Minnesota

Chaska, Minnesota, United States, 55318
United States, Missouri

Springfield, Missouri, United States, 65802
United States, Montana

Billings, Montana, United States, 59102

Billings, Montana, United States, 59101
United States, Nebraska

Lincoln, Nebraska, United States, 68510
United States, Nevada

Reno, Nevada, United States, 89502

Las Vegas, Nevada, United States, 89104
United States, New Jersey

New Brunswick, New Jersey, United States, 08901

Princeton, New Jersey, United States, 08540

Lawrenceville, New Jersey, United States, 08648
United States, New Mexico

Albuquerque, New Mexico, United States, 87102
United States, North Carolina

Winston-Salem, North Carolina, United States, 27103

Raleigh, North Carolina, United States, 27612
United States, North Dakota

Fargo, North Dakota, United States, 58105
United States, Ohio

Cleveland, Ohio, United States, 44122

Columbus, Ohio, United States, 43213
United States, Oklahoma

Tulsa, Oklahoma, United States, 74105

Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19114

Pittsburgh, Pennsylvania, United States, 15206

Erie, Pennsylvania, United States, 16502

Wexford, Pennsylvania, United States, 15090
United States, South Carolina

Columbia, South Carolina, United States, 29201
United States, South Dakota

Sioux Falls, South Dakota, United States, 57105
United States, Tennessee

Chattanooga, Tennessee, United States, 37404

Chattanooga, Tennessee, United States, 37403

Memphis, Tennessee, United States, 38120
United States, Texas

Houston, Texas, United States, 77004

Houston, Texas, United States, 77030

Dallas, Texas, United States, 75234
United States, Vermont

Burlington, Vermont, United States, 05401-1420
United States, Virginia

Norfolk, Virginia, United States, 23507

Richmond, Virginia, United States, 23294
United States, Washington

Seattle, Washington, United States, 98105

Renton, Washington, United States, 98055

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91493, 310184
Study First Received:	March 9, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00446199 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Vasomotor symptom relief
Postmenopausal women
Severe to Moderate Vasomotor symptoms

Additional relevant MeSH terms:

Signs and Symptoms
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Drospirenone
Hot Flashes
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009