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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Comprehensive Clinical Trials West Palm Beach, United States, 33409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Louis University Hospital St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Medicine and Dentistry of New Jersey New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rosemark Women Care Specialist Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northern Indiana Womens Heatlh Research, Inc. South Bend, United States, 46601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Planned Parenthood of Houston and SE Texas Houston, United States, 77004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Estrella Womens Health Center Phoenix, United States, 85031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southwest Clinical Research Albuquerque, United States, 87102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiant Research - San Diego San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wayne State University Detroit, United States, 48201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida-Gainesville Gainesville, United States, 32610-0254 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jean Brown Research Salt Lake City, United States, 84124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trials Research Services, LLC Pittsburgh, United States, 15206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Greater Hartford Women's Health Assoc. West Hartford, United States, 06117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care, Inc. San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Falcon Center for Women Peoria, United States, 61615 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medical Group of Northern Nevada Reno, United States, 89502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fletcher Allen Health Care Burlington, United States, 05401-1420 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacksonville Center for Clinical Research Jacksonville, United States, 32216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center of North Texas Arlington, United States, 76012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King's Daughters Hospital Temple, United States, 76502-1896 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Center for Clinical Research New Orleans, United States, 70115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Kentucky Lexington, United States, 40536 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Clinical Consulting New Orleans, United States, 70118-1034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiant Research - Cincinnati Cincinnati, United States, 45236 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Hospital of Central Connecticut New Britain, United States, 06050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atlanta Women's Research Institute, Inc. Alpharetta, United States, 30005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Clinical Therapeutics Tucson, United States, 85712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Center for Women's Health Research Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Philadelphia Clinical Research Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Women's Research Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stedman Clinical Trials Tampa, United States, 33613 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Adam Patterson OB-GYN Memphis, United States, 38120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Practice Champaign, United States, 61820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Affiliated Research Center Huntsville, United States, 35801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advances in Health, inc. Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rapid Medical Research Inc. Cleveland, United States, 44122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Today's Women's Health Chandler, United States, 85225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Associates Boise, United States, 83702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Study Center Fort Myers, United States, 33916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Douglas Young, MD Fair Oaks, United States, 95628 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Foundation for Osteoporsis Research and Education Oakland, United States, 94612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicenter, double-blind, randomized, placebo-controlled study comparing a 2.2mg 17 beta-estradiol/0.69mg levonorgestrel combination transdermal patch, and a 1mg 17 beta-estradiol transdermal patch with a placebo patch in postmenopausal women to determine the lowest effective dose of estradiol for the relief of moderate to severe hot flushes
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Lowest effective dose in decreasing the frequency and severity of hot flushesTimeframe:
Secondary Outcome
- Other symptoms related to menopauseTimeframe:
Additional Information
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