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

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Menostar (estradiol transdermal delivery system)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Menopause

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Evidence of postmenopausal status Exclusion Criteria: Contraindication to estrogen therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Relative change in frequency of hot flushes

    Secondary Outcome Measures

    Change in intensity of hot flushes
    Changes in vaginal pH
    Changes in vaginal maturation index
    Occurrence of urogenital symptoms
    Change in MENQOL (menopausal quality of life questionaire)
    Bleeding profile
    Safety

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    December 22, 2014
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00185237
    Brief Title
    Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hot Flashes
    Keywords
    Menopause

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Menostar (estradiol transdermal delivery system)
    Intervention Description
    Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo patch
    Primary Outcome Measure Information:
    Title
    Relative change in frequency of hot flushes
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in intensity of hot flushes
    Time Frame
    12 weeks
    Title
    Changes in vaginal pH
    Time Frame
    12 weeks
    Title
    Changes in vaginal maturation index
    Time Frame
    12 weeks
    Title
    Occurrence of urogenital symptoms
    Time Frame
    12 weeks
    Title
    Change in MENQOL (menopausal quality of life questionaire)
    Time Frame
    12 weeks
    Title
    Bleeding profile
    Time Frame
    12 weeks
    Title
    Safety
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Evidence of postmenopausal status Exclusion Criteria: Contraindication to estrogen therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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