Vasomotor Symptoms Clinical Trial
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.
Verified date | September 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 249 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of hot flushes | From baseline to week 16 | No | |
Primary | Change in intensity of hot flushes | From baseline to week 16 | No | |
Secondary | Change in other climacteric symptoms | From baseline to week 16 | No | |
Secondary | Vaginal Bleeding pattern | From baseline to week 16 | Yes | |
Secondary | Global clinical impression | From baseline to week 16 | No |
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