To evaluate the safety, tolerability, and efficacy of Angeliq® in Thai post menopausal women with hot flushes and other climacteric symptoms...
Date First Received: September 12, 2005
Last Updated: May 1, 2007
Verified by: Bayer, October 2006
Clinical Trial Phase: N/A | Start Date: August 2005
Overall Status: Active, not recruiting
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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, Parallel Assignment, Safety/Efficacy Study
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
- Drug: Drospirenone
Outcome Measures for this Clinical Trial
Primary Measures
- This study aims to evaluate the safety, tolerability and efficacy of Angeliq® in Thai postmenopausal women with hot flushes and other climacteric and urogenital symptoms.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal women with hot flushes
Exclusion Criteria:
- Women with a contraindication for HRT
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Bayer
Overall Clinical Trial Officials and Contacts
Bayer Schering Pharma AG, Germany, Medical Affairs, Region Asia/ Pacific Study Director +65 6511 6194
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185328
Study ID Number: 309367
ClinicalTrials.gov Identifier: NCT00185328
Health Authority: Thailand: Food and Drug Administration
Clinical Trials Authorship and Review
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