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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00651599 |
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.
Condition | Intervention | Phase |
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Vasomotor Symptoms |
Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle |
Enrollment: | 72 |
Study Start Date: | July 2004 |
Study Completion Date: | May 2005 |
Arms | Assigned Interventions |
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Arm 2: Placebo Comparator |
Drug: Placebo
Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
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Arm 1: Experimental |
Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
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Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul, Korea, Republic of, 110-744 | |
Seoul, Korea, Republic of, 138-736 | |
Seoul, Korea, Republic of, 135-710 | |
Seoul, Korea, Republic of |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91354, 308381 |
Study First Received: | April 1, 2008 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00651599 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Vasomotor symptoms Vasomotor System |
Estrogens Aldosterone Antagonists Hormone Antagonists Estradiol 3-benzoate Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists |
Drospirenone Estradiol 17 beta-cypionate Polyestradiol phosphate Hormones Estradiol Menopause |
Estrogens Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Drospirenone Hormones Pharmacologic Actions Estradiol |