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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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: Angeliq®
  • Drospirenone 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
  • n/a
• Placebo Comparator: Arm 2
  • n/a

Primary Measures

• Frequency of hot flushes
  • Time Frame: From baseline to week 16
    Safety Issue?: No
• Change in intensity of hot flushes
  • Time Frame: From baseline to week 16
    Safety Issue?: No

Secondary Measures

• Change in other climacteric symptoms
  • Time Frame: From baseline to week 16
    Safety Issue?: No
• Vaginal Bleeding pattern
  • Time Frame: From baseline to week 16
    Safety Issue?: Yes
• Global clinical impression
  • Time Frame: From baseline to week 16
    Safety Issue?: No

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

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

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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