Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vasomotor Symptoms
Intervention: Angeliq® (2 mg drospirenone and 1 mg estradiol) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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®.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Hot flush (frequency and severity)
Secondary outcome: Menopausal symptomsUrogenital symptoms Assessment of bleeding
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal Korean women suffering from hot flushes
Exclusion Criteria:
- Standard exclusion criteria for HRT clinical trials had to be obeyed, including
current or history of hormone dependent malignant disease, thromboembolic disorders,
abnormal cervical smear, undiagnosed vaginal bleeding.
Locations and Contacts
Seoul 110-744, Korea, Republic of
Seoul 135-710, Korea, Republic of
Seoul, Korea, Republic of
Additional Information
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Starting date: July 2004
Ending date: May 2005
Last updated: April 2, 2008
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