Trial Condition(s):
Vasomotor Symptoms, Hot Flashes
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
Bayer Identifier:
91493
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Eastern Virginia Medical School Norfolk, United States, 23507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Medicine and Dentistry of New Jersey New Brunswick, United States, 08901 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trials Research Services, LLC Pittsburgh, United States, 15206 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care Specialist Paw Paw, United States, 49079 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Planned Parenthood of Houston and SE Texas Houston, United States, 77004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Blue Skies Center for Women Colorado Springs, United States, 80910 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OB-GYN Centre of Excellence Chattanooga, United States, 37404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hawthorne Medical Research, Inc. Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medical Group of Northern Nevada Reno, United States, 89502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princeton Genetics Research, LLC Princeton, United States, 08540 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fletcher Allen Health Care Burlington, United States, 05401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinical Research Center DBA Seattle Women's Health Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Hospital of Central Connecticut New Britain, United States, 06050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Planned Parenthood of Arkansas and Eastern Oklahoma Tulsa, United States, 74105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeastern Clinical Research Chattanooga, United States, 37403 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Clinical Consulting Marrero, United States, 70072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Elite Research Institute Miami, United States, 33169 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Clinical Therapeutics Tucson, United States, 85712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Research Institute New Port Richey, United States, 34655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advances in Health, inc. Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Center for Women's Health Research Columbus, United States, 43213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Valley Women's Clinic Renton, United States, 98055 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Infertility, Gynecology & Obstetrics Med. Group San Diego, United States, 92121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Across America Dallas, United States, 75234 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Today's Women's Health Chandler, United States, 85225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genova Clinical Research Inc Tucson, United States, 85741 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Insignia Clinical Research Tampa, United States, 33607 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Associates Boise, United States, 83702 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Clinical Consulting Amite, United States, 70422 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cetero Research Fargo, United States, 58105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive Clinical Trials West Palm Beach, United States, 33409 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Boynton Beach, United States, 33437 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rosemark Women Care Specialist Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rapid Medical Research Inc. Cleveland, United States, 44122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations WomanCare Arlington Heights, United States, 60004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Avera Research Institute Sioux Falls, United States, 57105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Age Medical Research Corp. Miami, United States, 33186 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida Women's Health- Specialists Emerson Jacksonville, United States, 32216 | Status Completed | Contact Us: E-mail: clinical-tria[email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Carolina Clinical Research Center Columbia, United States, 29201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ridgeview Research Chaska, United States, 55318 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Physiology Associates, Inc. Fort Myers, United States, 33916 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Women's Specialist of Houston Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Kentucky Lexington, United States, 40536 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Adam Patterson OB-GYN Memphis, United States, 38120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Clinical Research, Inc. Richmond, United States, 23294 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Alfred Moffett, MD Leesburg, United States, 34748 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Clinical Research, Inc Mobile, United States, 36608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayview Research Group, LLC Paramount, United States, 90723 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Clinical Research Atlanta, United States, 30328 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Montana Health Research Institute Billings, United States, 59102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bio-Kinetic Clinical Applications Springfield, United States, 65802 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayview Research Group, LLC Valley Village, United States, 91607 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Coast Women's Care, Inc Vista, United States, 92083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soapstone Center for Clinical Research Decatur, United States, 30034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care, Inc. San Diego, United States, 92123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tampa Bay Medical Research, Inc. Clearwater, United States, 33761 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Center of Nevada Las Vegas, United States, 89104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OB/GYN Associates of Erie Erie, United States, 16502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lyndhurst Gynecologic Associates Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atlantic Institute of Clinical Research Daytona Beach, United States, 32114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Downtown Women's Healthcare Denver, United States, 80218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Loyola University Health System - LaGrange Park La Grange Park, United States, 60526 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Research Asssociates Raleigh, United States, 27612 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southwest Clinical Research Albuquerque, United States, 87102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wellborn Clinic Newburgh Newburgh, United States, 47630 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Practice Champaign, United States, 61820 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altus Research Lake Worth, United States, 33461 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Susan Floyd, MD Wexford, United States, 15090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations COR Clinical Research, LLC Oklahoma City, United States, 73103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Estrella Womens Health Center Phoenix, United States, 85031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altanta Women's Research Institute, Inc. Atlanta, United States, 30342 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Billings Clinic Research Center Billings, United States, 59101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Woman's Clinic, P.A. Little Rock, United States, 72205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Research Center, LLC Lawrenceville, United States, 08648 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Change from baseline to week 12 in weekly frequency of moderate to severe hot flushes (median value)Timeframe: Baseline until 12 weeks of treatment
- Change from baseline to week 4 in weekly frequency of moderate to severe hot flushes (median value)Timeframe: Baseline until 4 weeks of treatment
- Change from baseline to week 12 in weekly mean daily severity of moderate to severe hot flushes (median value)Timeframe: Baseline until 12 weeks of treatment
- Change from baseline to week 4 in weekly mean daily severity of moderate to severe hot flushes (median value)Timeframe: Baseline until 4 weeks of treatment
Secondary Outcome
- Change from baseline to week 12 in vaginal pHTimeframe: Baseline until 12 weeks of treatment
- Change from baseline to week 12 in vaginal maturation valueTimeframe: Baseline until 12 weeks of treatment
- Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'Vaginal dryness'Timeframe: After 12 weeks of treatment
- Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'vaginal and/or vulvar irritation/itching'Timeframe: After 12 weeks of treatment
- Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'dysuria'Timeframe: After 12 weeks of treatment
- Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'vaginal pain associated with sexual activity'Timeframe: After 12 weeks of treatment
- Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'vaginal bleeding associated with sexual activity'Timeframe: After 12 weeks of treatment
- Urogenital symptoms: Number of participants with Symptom 'Frequent urination'Timeframe: After 12 weeks of treatment
- Urogenital symptoms: Number of participants with Symptom 'involuntary urination when laughing or coughing'Timeframe: After 12 weeks of treatment
- Urogenital symptoms: Number of participants with Symptom 'urination at night'Timeframe: After 12 weeks of treatment
Additional Information
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