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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 superior to placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms.
Safety and tolerability of Angeliq®.
Condition | Intervention | Phase |
---|---|---|
Vasomotor Symptoms |
Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol) 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 |
---|---|
Arm 1: Experimental
n/a
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Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol)
Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
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Arm 2: Placebo Comparator
n/a
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Drug: Placebo
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:
Responsible Party: | ( Bayer Schering Pharma AG, Therapeutic Area Head ) |
Study ID Numbers: | 91354, 308381 |
Study First Received: | April 1, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00651599 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Vasomotor symptoms Vasomotor System |
Estradiol 3-benzoate Estradiol valerate Drospirenone Estradiol 17 beta-cypionate |
Polyestradiol phosphate Estradiol Menopause |
Estrogens Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |