check_circleStudy Completed

Hot Flashes

Bayer Identifier:

91441

ClinicalTrials.gov Identifier:

NCT00185237

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment of hot flushes in Asian women with ultra-low dose estradiol patch

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years
  • - Evidence of postmenopausal status
  • - Contraindication to estrogen therapy

Trial summary

Enrollment Goal
165
Trial Dates
July 2005 - November 2006
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Menostar (E2 transdermal, BAY86-5435)
Accepts Healthy Volunteer
No

Primary Outcome

  • Relative change in frequency of hot flushes
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change in intensity of hot flushes
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Changes in vaginal pH
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Changes in vaginal maturation index
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Occurrence of urogenital symptoms
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Change in MENQOL (menopausal quality of life questionaire)
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Bleeding profile
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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