Low-Dose Hormone Therapy for Relief of Vasomotor Symptoms

Condition(s) targeted: Vasomotor Symptoms; Hot Flashes

Intervention: drospirenone/17β-estradiol (Drug); 17β-estradiol (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Manager, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Mean change from baseline to Week 12 in weekly frequency of moderate to severe hot flushes

Mean change from baseline to Week 12 in weekly mean daily severity of moderate to severe hot flushes

Mean change from baseline to Week 4 in weekly frequency of moderate to severe hot flushes

Mean change from baseline to Week 4 in weekly mean daily severity of moderate to severe hot flushes

Secondary outcome:

Mean change from baseline to Week 12 in vaginal pH and vaginal maturation index

Symptoms of vulvar and vaginal atrophy and urogenital symptoms at baseline and Week 12

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.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Female.

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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Estrella Women's Health Center, Phoenix, Arizona 85037, United States; Recruiting

Visions Clinical Research Tucson, Tucson, Arizona 85712, United States; Recruiting

Advanced Clinical Therapeutics, Tucson, Arizona 85712, United States; Recruiting

Today's Women's Health, Chandler, Arizona 85225, United States; Recruiting

Genova Clinical Research, Inc., Tucson, Arizona 85741, United States; Recruiting

Medical Center for Clinical Research, San Diego, California 92108, United States; Recruiting

Genesis Center for Clinical Research, San Diego, California 92103, United States; Recruiting

Bayview Research Group, LLC, Paramount, California 90723, United States; Recruiting

Women's Health Care, San Diego, California 92123, United States; Recruiting

Infertility, Gynecology, & Ob. Med. Group, San Diego, California 92121, United States; Recruiting

Blue Skies Center for Women, Colorado Springs, Colorado 80910, United States; Recruiting

Downtown Women's Healthcare, Denver, Colorado 80218, United States; Recruiting

The Center for Fertility & Women's Health, PC New Britain General Hospital, New Britain, Connecticut 06050, United States; Recruiting

Comprehensive Clinical Trials, West Palm Beach, Florida 33409, United States; Recruiting

Visions Clinical Research, Boynton Beach, Florida 33437, United States; Withdrawn

New Age Medical Research Corporation, Miami, Florida 33186, United States; Recruiting

Insignia Clinical Research, Tampa, Florida 33607, United States; Recruiting

Clinical Physiology Associates, Inc., Fort Myers, Florida 33916, United States; Recruiting

Altus Research, Lake Worth, Florida 33461, United States; Recruiting

Elite Research Institute, Miami, Florida 33169, United States; Recruiting

Advanced Research Institute, Inc., New Port Richey, Florida 34655, United States; Recruiting

Atlantic Institute of Clinical Research, Daytona Beach, Florida 32114, United States; Recruiting

Mount Vernon Clinical Research, Atlanta, Georgia 30328, United States; Recruiting

Rosemark Women's Care Specialists, Idaho Falls, Idaho 83404, United States; Recruiting

Research Associates, Boise, Idaho 83702, United States; Recruiting

WomanCare, Arlington Heights, Illinois 60004, United States; Recruiting

Loyola University Medical Center, LaGrange Park, Illinois 60526, United States; Recruiting

York Clinical Consulting, Marrero, Louisiana 70072, United States; Recruiting

York Clinical Consulting, Amite, Louisiana 70422, United States; Recruiting

Women's Health Care Specialist, Paw Paw, Michigan 49079, United States; Recruiting

Ridgeview Research, Chaska, Minnesota 55318, United States; Recruiting

Women's Clinic of Lincoln, PC, Lincoln, Nebraska 68510, United States; Recruiting

The Medical Group of Northern Nevada, Reno, Nevada 89502, United States; Recruiting

Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States; Recruiting

Princeton Genetic Research, LLC, Princeton, New Jersey 08540, United States; Recruiting

Southwest Clinical Research, Albuquerque, New Mexico 87102, United States; Recruiting

Hawthorne Medical Research, Inc., Winston-Salem, North Carolina 27103, United States; Recruiting

Lyndhurst Gynecologic Associates, Winston-Salem, North Carolina 27103, United States; Recruiting

PRACS Insitiute LTD, Fargo, North Dakota 58104, United States; Terminated

Rapid Medical Research, Inc., Cleveland, Ohio 44122, United States; Recruiting

The Columbus Center for Women's Health Research, Columbus, Ohio 43213, United States; Recruiting

Philadelphia Clinical Research, LLC, Philadelphia, Pennsylvania 19114, United States; Recruiting

Clinical Trials Research Services, LLC, Pittsburgh, Pennsylvania 15206, United States; Recruiting

Wexford Professional Building III, Wexford, Pennsylvania 15090, United States; Recruiting

Square-1 Clinical Research, LLC, Erie, Pennsylvania 16506, United States; Recruiting

SC Clinical Research Center, Columbia, South Carolina 29201, United States; Recruiting

Avera Research Institute, Sioux Falls, South Dakota 57105, United States; Recruiting

OB-GYN Center of Excellence, Chattanooga, Tennessee 37404, United States; Recruiting

Gynecology and Obstetrics, Memphis, Tennessee 38120, United States; Recruiting

Planned Parenthood of Arkansas and Eastern OK, Houston, Texas 77004, United States; Recruiting

Advances in Health Inc., Houston, Texas 77030, United States; Recruiting

Research Across America, Dallas, Texas 75234, United States; Recruiting

The Women's Specialist of Houston, Houston, Texas 77074, United States; Recruiting

Clinical Research Center, Norfolk, Virginia 23507, United States; Not yet recruiting

National Clinical Research, Inc., Richmond, Virginia 23294, United States; Recruiting

Women's Clinical Research Center, Seattle, Washington 98105, United States; Recruiting

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Starting date: March 2007
Ending date: October 2008
Last updated: November 27, 2007