Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vasomotor Symptoms
Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (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 better than 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 138-736, Korea, Republic of
Seoul, Korea, Republic of
Additional Information
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Starting date: July 2004
Last updated: December 30, 2014
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