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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

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: Menostar (estradiol transdermal delivery system) Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Drug: Menostar (estradiol transdermal delivery system)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Placebo Comparator: Arm 2 Drug: Placebo
Placebo patch




Primary Outcome Measures :
  1. Relative change in frequency of hot flushes [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in intensity of hot flushes [ Time Frame: 12 weeks ]
  2. Changes in vaginal pH [ Time Frame: 12 weeks ]
  3. Changes in vaginal maturation index [ Time Frame: 12 weeks ]
  4. Occurrence of urogenital symptoms [ Time Frame: 12 weeks ]
  5. Change in MENQOL (menopausal quality of life questionaire) [ Time Frame: 12 weeks ]
  6. Bleeding profile [ Time Frame: 12 weeks ]
  7. Safety [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of postmenopausal status

Exclusion Criteria:

  • Contraindication to estrogen therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185237


Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185237    
Other Study ID Numbers: 91441
309120
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Menopause
Additional relevant MeSH terms:
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Hot Flashes
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs