Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
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® (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
The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and
estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor
symptoms) and uro-genital complaints.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-Day Treatment Cycles.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Frequency of hot flushesChange in intensity of hot flushes
Secondary outcome: Change in other climacteric symptomsVaginal Bleeding pattern Global clinical impression
Detailed description:
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.
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Chinese postmenopausal women with moderate to severe vasomotor symptoms
Exclusion Criteria:
- History of steroid hormone dependent malignant disease
- Known or suspected malignant or premalignant disease
- Current or history of severe heart, liver, renal, psychiatric disease
- Hyperlipemia
Locations and Contacts
Beijing 100730, China
Beijing 100089, China
Beijing 100083, China
Beijing 100020, China
Shanghai 200011, China
Chongqing 400010, China
Wuhan, Hubei province 430022, China
Nanjing, Jiangsu 210029, China
Jinan, Shandong 250012, China
Additional Information
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Starting date: May 2006
Ending date: October 2007
Last updated: May 26, 2008
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