check_circleStudy Completed

Vasomotor symptoms, Hot Flashes

Bayer Identifier:

91493

ClinicalTrials.gov Identifier:

NCT00446199

EudraCT Number:

Not Available

EU CT Number:

Not Available
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

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.

Key Participants Requirements

Sex

Female

Age

40 Years
  • - 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
  • - The usual exclusion criteria for hormone therapy apply
    - Intake of medications other than hormones affecting hot flushes

Trial summary

Enrollment Goal
735
Trial Dates
March 2007 - November 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Low-Dose E2/DRSP (BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
University of Medicine and Dentistry of New JerseyNew Brunswick, 08901, United States
Completed
Clinical Trials Research Services, LLCPittsburgh, 15206, United States
Completed
Women's Health Care SpecialistPaw Paw, 49079, United States
Completed
Planned Parenthood of Houston and SE TexasHouston, 77004, United States
Completed
Blue Skies Center for WomenColorado Springs, 80910, United States
Completed
OB-GYN Centre of ExcellenceChattanooga, 37404, United States
Completed
Hawthorne Medical Research, Inc.Winston-Salem, 27103, United States
Completed
The Medical Group of Northern NevadaReno, 89502, United States
Completed
Princeton Genetics Research, LLCPrinceton, 08540, United States
Completed
Fletcher Allen Health CareBurlington, 05401, United States
Completed
Women's Clinical Research Center DBA Seattle Women's HealthSeattle, 98105, United States
Completed
The Hospital of Central ConnecticutNew Britain, 06050, United States
Completed
Planned Parenthood of Arkansas and Eastern OklahomaTulsa, 74105, United States
Completed
Southeastern Clinical ResearchChattanooga, 37403, United States
Completed
York Clinical ConsultingMarrero, 70072, United States
Completed
Elite Research InstituteMiami, 33169, United States
Completed
Advanced Clinical TherapeuticsTucson, 85712, United States
Completed
Advanced Research InstituteNew Port Richey, 34655, United States
Completed
Advances in Health, inc.Houston, 77030, United States
Completed
Columbus Center for Women's Health ResearchColumbus, 43213, United States
Completed
Valley Women's ClinicRenton, 98055, United States
Completed
Infertility, Gynecology & Obstetrics Med. GroupSan Diego, 92121, United States
Completed
Research Across AmericaDallas, 75234, United States
Completed
Women's Clinic of Lincoln, PCLincoln, 68510, United States
Completed
Today's Women's HealthChandler, 85225, United States
Completed
Genova Clinical Research IncTucson, 85741, United States
Completed
Insignia Clinical ResearchTampa, 33607, United States
Completed
Research AssociatesBoise, 83702, United States
Completed
York Clinical ConsultingAmite, 70422, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Cetero ResearchFargo, 58105, United States
Completed
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
Visions Clinical ResearchBoynton Beach, 33437, United States
Completed
Rosemark Women Care SpecialistIdaho Falls, 83404, United States
Completed
Rapid Medical Research Inc.Cleveland, 44122, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
WomanCareArlington Heights, 60004, United States
Completed
Avera Research InstituteSioux Falls, 57105, United States
Completed
New Age Medical Research Corp.Miami, 33186, United States
Completed
Visions Clinical Research - TucsonTucson, 85712, United States
Completed
University of Florida Women's Health- Specialists EmersonJacksonville, 32216, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
South Carolina Clinical Research CenterColumbia, 29201, United States
Completed
Ridgeview ResearchChaska, 55318, United States
Completed
Clinical Physiology Associates, Inc.Fort Myers, 33916, United States
Completed
The Women's Specialist of HoustonHouston, 77030, United States
Completed
University of KentuckyLexington, 40536, United States
Completed
Adam Patterson OB-GYNMemphis, 38120, United States
Completed
National Clinical Research, Inc.Richmond, 23294, United States
Completed
Office of Dr. Alfred Moffett, MDLeesburg, 34748, United States
Completed
Coastal Clinical Research, IncMobile, 36608, United States
Completed
Bayview Research Group, LLCParamount, 90723, United States
Completed
Mount Vernon Clinical ResearchAtlanta, 30328, United States
Completed
Montana Health Research InstituteBillings, 59102, United States
Completed
Bio-Kinetic Clinical ApplicationsSpringfield, 65802, United States
Completed
Bayview Research Group, LLCValley Village, 91607, United States
Completed
North Coast Women's Care, IncVista, 92083, United States
Completed
Soapstone Center for Clinical ResearchDecatur, 30034, United States
Completed
Women's Health Care, Inc.San Diego, 92123, United States
Completed
Tampa Bay Medical Research, Inc.Clearwater, 33761, United States
Completed
Clinical Research Center of NevadaLas Vegas, 89104, United States
Completed
OB/GYN Associates of ErieErie, 16502, United States
Completed
Lyndhurst Gynecologic AssociatesWinston-Salem, 27103, United States
Completed
Atlantic Institute of Clinical ResearchDaytona Beach, 32114, United States
Completed
Downtown Women's HealthcareDenver, 80218, United States
Completed
Loyola University Health System - LaGrange ParkLa Grange Park, 60526, United States
Completed
Wake Research AsssociatesRaleigh, 27612, United States
Completed
Southwest Clinical ResearchAlbuquerque, 87102, United States
Completed
Wellborn Clinic NewburghNewburgh, 47630, United States
Completed
Women's Health PracticeChampaign, 61820, United States
Completed
Altus ResearchLake Worth, 33461, United States
Completed
Dr. Susan Floyd, MDWexford, 15090, United States
Completed
COR Clinical Research, LLCOklahoma City, 73103, United States
Completed
Estrella Womens Health CenterPhoenix, 85031, United States
Completed
Altanta Women's Research Institute, Inc.Atlanta, 30342, United States
Completed
Billings Clinic Research CenterBillings, 59101, United States
Completed
The Woman's Clinic, P.A.Little Rock, 72205, United States
Completed
Women's Health Research Center, LLCLawrenceville, 08648, United States

Primary Outcome

  • Change from baseline to week 12 in weekly frequency of moderate to severe hot flushes (median value)
    date_rangeTime Frame:
    Baseline until 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to week 4 in weekly frequency of moderate to severe hot flushes (median value)
    date_rangeTime Frame:
    Baseline until 4 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to week 12 in weekly mean daily severity of moderate to severe hot flushes (median value)
    date_rangeTime Frame:
    Baseline until 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to week 4 in weekly mean daily severity of moderate to severe hot flushes (median value)
    date_rangeTime Frame:
    Baseline until 4 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change from baseline to week 12 in vaginal pH
    date_rangeTime Frame:
    Baseline until 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to week 12 in vaginal maturation value
    date_rangeTime Frame:
    Baseline until 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'Vaginal dryness'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'vaginal and/or vulvar irritation/itching'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'dysuria'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'vaginal pain associated with sexual activity'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Symptoms of vulvar and vaginal atrophy: Severity of Symptom 'vaginal bleeding associated with sexual activity'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Urogenital symptoms: Number of participants with Symptom 'Frequent urination'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Urogenital symptoms: Number of participants with Symptom 'involuntary urination when laughing or coughing'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Urogenital symptoms: Number of participants with Symptom 'urination at night'
    date_rangeTime Frame:
    After 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.