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

• ClinicalTrials.gov Identifier: NCT00185237
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Last Update Posted: December 23, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: December 23, 2014
• Study Start Date: July 2005
• Actual Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 29, 2008): Relative change in frequency of hot flushes [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures (submitted: September 9, 2005): Relative change from baseline to Week 12 in frequency of hot flushes

Current Secondary Outcome Measures (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 (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: 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.
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hot Flashes

Intervention

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

Study Arms

• Experimental: Arm 1
  Intervention: Drug: Menostar (estradiol transdermal delivery system)
• Placebo Comparator: Arm 2
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2014): 165
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2006
• Actual Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Evidence of postmenopausal status

Exclusion Criteria:

• Contraindication to estrogen therapy

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Hong Kong, Malaysia, Philippines, Singapore, Thailand

Administrative Information

• NCT Number: NCT00185237
• Other Study ID Numbers: 91441; 309120
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bayer
• Study Sponsor: Bayer
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: December 2014