check_circleStudy Completed

Hot Flashes

Bayer Identifier:

91429

ClinicalTrials.gov Identifier:

NCT00206622

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and Safety study in postmenopausal women to determine the lowest effective dose for relief of moderate to severe hot-flushes

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

Key Participants Requirements

Sex

Female

Age

40 Years
  • - 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)
  • - Hormonal treatment- Contraindication to estrogen/progestogen therapy

Trial summary

Enrollment Goal
425
Trial Dates
December 2004 - February 2006
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Climara PRO (E2/LNG)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
St. Louis University HospitalSt. Louis, 63110, United States
Completed
University of Medicine and Dentistry of New JerseyNew Brunswick, 08901, United States
Completed
Rosemark Women Care SpecialistIdaho Falls, 83404, United States
Completed
Northern Indiana Womens Heatlh Research, Inc.South Bend, 46601, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
Planned Parenthood of Houston and SE TexasHouston, 77004, United States
Completed
Estrella Womens Health CenterPhoenix, 85031, United States
Completed
Southwest Clinical ResearchAlbuquerque, 87102, United States
Completed
Radiant Research - San DiegoSan Diego, 92108, United States
Completed
Visions Clinical Research - TucsonTucson, 85712, United States
Completed
Wayne State UniversityDetroit, 48201, United States
Completed
University of Florida-GainesvilleGainesville, 32610-0254, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Jean Brown ResearchSalt Lake City, 84124, United States
Completed
Clinical Trials Research Services, LLCPittsburgh, 15206, United States
Completed
Greater Hartford Women's Health Assoc.West Hartford, 06117, United States
Completed
Women's Health Care, Inc.San Diego, 92123, United States
Completed
Falcon Center for WomenPeoria, 61615, United States
Completed
Radiant Research - San DiegoSan Diego, 92108, United States
Completed
The Medical Group of Northern NevadaReno, 89502, United States
Completed
Fletcher Allen Health CareBurlington, 05401-1420, United States
Completed
Jacksonville Center for Clinical ResearchJacksonville, 32216, United States
Completed
Medical Center of North TexasArlington, 76012, United States
Completed
King's Daughters HospitalTemple, 76502-1896, United States
Completed
Women's Center for Clinical ResearchNew Orleans, 70115, United States
Completed
University of KentuckyLexington, 40536, United States
Completed
York Clinical ConsultingNew Orleans, 70118-1034, United States
Completed
Radiant Research - CincinnatiCincinnati, 45236, United States
Completed
The Hospital of Central ConnecticutNew Britain, 06050, United States
Completed
Atlanta Women's Research Institute, Inc.Alpharetta, 30005, United States
Completed
Advanced Clinical TherapeuticsTucson, 85712, United States
Completed
Columbus Center for Women's Health ResearchColumbus, 43213, United States
Completed
Philadelphia Clinical ResearchPhiladelphia, 19114, United States
Completed
Center for Women's ResearchChicago, 60612, United States
Completed
Stedman Clinical TrialsTampa, 33613, United States
Completed
Adam Patterson OB-GYNMemphis, 38120, United States
Completed
Women's Health PracticeChampaign, 61820, United States
Completed
Medical Affiliated Research CenterHuntsville, 35801, United States
Completed
Advances in Health, inc.Houston, 77030, United States
Completed
Lyndhurst Gynecologic AssociatesWinston-Salem, 27103, United States
Completed
Women's Clinic of Lincoln, PCLincoln, 68510, United States
Completed
Rapid Medical Research Inc.Cleveland, 44122, United States
Completed
Today's Women's HealthChandler, 85225, United States
Completed
Research AssociatesBoise, 83702, United States
Completed
Clinical Study CenterFort Myers, 33916, United States
Completed
Douglas Young, MDFair Oaks, 95628, United States
Completed
Foundation for Osteoporsis Research and EducationOakland, 94612, United States

Primary Outcome

  • Lowest effective dose in decreasing the frequency and severity of hot flushes
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Other symptoms related to menopause
    enhanced_encryption
    Safety Issue:
    None

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

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 marketed products.