Official Title: “A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles”

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group 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: Estradiol/DRSP (Angeliq, BAY86-4891)
  • 1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• The relative change in the frequency of hot flushes
  • Time Frame: At baseline, week 4, 8, 12
    

Secondary Measures

• The change in intensity of hot flushes
  • Time Frame: At baseline, week 4, 8, 12
    
• The relative change in frequency of hot flushes
  • Time Frame: At baseline, week 4, 8
    
• The change in intensity of hot flushes
  • Time Frame: At baseline, week 4, 8
    
• The proportions of subjects with urogenital symptoms
  • Time Frame: At baseline, week 4, 8, 12
    
• Bleeding pattern
  • Time Frame: At baseline, week 4, 8, 12
    
• Adverse events collection
  • Time Frame: Collection of AE throughout the study period
    

Inclusion Criteria:

• Postmenopausal women with hot flushes

Exclusion Criteria:

• Women with a contraindication for Hormone Replacement Therapy (HRT)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185328

Study ID Number: 91436

ClinicalTrials.gov Identifier: NCT00185328

Health Authority: Thailand: Food and Drug Administration

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