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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Menostar (estradiol transdermal delivery system)
  • Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
• Drug: Placebo
  • Placebo patch

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Relative change in frequency of hot flushes
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change in intensity of hot flushes
  • Time Frame: 12 weeks
    Safety Issue?: No
• Changes in vaginal pH
  • Time Frame: 12 weeks
    Safety Issue?: No
• Changes in vaginal maturation index
  • Time Frame: 12 weeks
    Safety Issue?: No
• Occurrence of urogenital symptoms
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in MENQOL (menopausal quality of life questionaire)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Bleeding profile
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Evidence of postmenopausal status

Exclusion Criteria:

• Contraindication to estrogen therapy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185237

Study ID Number: 91441

ClinicalTrials.gov Identifier: NCT00185237

Health Authority: Singapore: Health Sciences Authority

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