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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00185237 |
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 | Intervention | Phase |
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Hot Flashes |
Drug: Menostar (estradiol transdermal delivery system) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Enrollment: | 283 |
Study Start Date: | July 2005 |
Study Completion Date: | November 2006 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Menostar (estradiol transdermal delivery system)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
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Arm 2: Placebo Comparator |
Drug: Placebo
Placebo patch
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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.
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91441, 309120 |
Study First Received: | September 9, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00185237 |
Health Authority: | Singapore: Health Sciences Authority; Hong Kong: Department of Health; Malaysia: Ministry of Health; Thailand: Food and Drug Administration; Philippines: Bureau of Food and Drugs |
Menopause |
Signs and Symptoms Benzoates Estradiol 3-benzoate Estradiol valerate Hot Flashes |
Flushing Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol Menopause |
Estrogens Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptive Agents, Female |
Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |