Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
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...
Brief Summary
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.”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: October 2007
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
- Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.
- Drug: Placebo
- Same administration.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Arm 1
- Placebo Comparator: Arm 2
Outcome Measures for this Clinical Trial
Primary Measures
- Frequency of hot flushes
- Time Frame: From baseline to week 16
Safety Issue?: No
- Time Frame: From baseline to week 16
- Change in intensity of hot flushes
- Time Frame: From baseline to week 16
Safety Issue?: No
- Time Frame: From baseline to week 16
Secondary Measures
- Change in other climacteric symptoms
- Time Frame: From baseline to week 16
Safety Issue?: No
- Time Frame: From baseline to week 16
- Vaginal Bleeding pattern
- Time Frame: From baseline to week 16
Safety Issue?: Yes
- Time Frame: From baseline to week 16
- Global clinical impression
- Time Frame: From baseline to week 16
Safety Issue?: No
- Time Frame: From baseline to week 16
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356447
Study ID Number: 91442
ClinicalTrials.gov Identifier: NCT00356447
Health Authority: China: State Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00356447
