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Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185237
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date December 23, 2014
Study Start Date  ICMJE July 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Relative change in frequency of hot flushes [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Relative change from baseline to Week 12 in frequency of hot flushes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • Change in intensity of hot flushes [ Time Frame: 12 weeks ]
  • Changes in vaginal pH [ Time Frame: 12 weeks ]
  • Changes in vaginal maturation index [ Time Frame: 12 weeks ]
  • Occurrence of urogenital symptoms [ Time Frame: 12 weeks ]
  • Change in MENQOL (menopausal quality of life questionaire) [ Time Frame: 12 weeks ]
  • Bleeding profile [ Time Frame: 12 weeks ]
  • Safety [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • - Effects on futher climacteric symptoms, e.g. vaginal atrophy.
  • - Quality of Life
  • - Bleeding pattern
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.
Brief Summary 150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.
Detailed Description The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hot Flashes
Intervention  ICMJE
  • Drug: Menostar (estradiol transdermal delivery system)
    Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
  • Drug: Placebo
    Placebo patch
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Menostar (estradiol transdermal delivery system)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2014)
165
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of postmenopausal status

Exclusion Criteria:

  • Contraindication to estrogen therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Hong Kong,   Malaysia,   Philippines,   Singapore,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT00185237
Other Study ID Numbers  ICMJE 91441
309120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP