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: December 11, 2008
Verified by: Bayer, December 2008
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 55
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, Single Group 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/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
Outcome Measures for this Clinical Trial
Primary Measures
- The relative change in the frequency of hot flushes
- Time Frame: At baseline, week 4, 8, 12
- 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
- Time Frame: At baseline, week 4, 8, 12
- The relative change in frequency of hot flushes
- Time Frame: At baseline, week 4, 8
- Time Frame: At baseline, week 4, 8
- The change in intensity of hot flushes
- Time Frame: At baseline, week 4, 8
- Time Frame: At baseline, week 4, 8
- The proportions of subjects with urogenital symptoms
- Time Frame: At baseline, week 4, 8, 12
- Time Frame: At baseline, week 4, 8, 12
- Bleeding pattern
- Time Frame: At baseline, week 4, 8, 12
- Time Frame: At baseline, week 4, 8, 12
- Adverse events collection
- Time Frame: Collection of AE throughout the study period
- Time Frame: Collection of AE throughout the study period
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Bayer
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
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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