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, 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: Estradiol
• Drug: Drospirenone

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.

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

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Schering Pharma AG, Germany, Medical Affairs, Region Asia/ Pacific Study Director +65 6511 6194  

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