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Efficacy and Tolerability in Thai Women

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause

Intervention: Estradiol (Drug); Drospirenone (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs, Region Asia/ Pacific, Study Director, Affiliation: +65 6511 6194

Summary

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

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Detailed 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.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women with hot flushes

Exclusion Criteria:

- Women with a contraindication for HRT

Locations and Contacts

Additional Information

Starting date: August 2005
Last updated: May 1, 2007

Page last updated: June 20, 2008

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