Efficacy and Tolerability of Angeliq in Thai Women
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Estradiol/DRSP (Angeliq, BAY86-4891) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The relative change in the frequency of hot flushes
Secondary outcome: The change in intensity of hot flushesThe relative change in frequency of hot flushes The change in intensity of hot flushes The proportions of subjects with urogenital symptoms Bleeding pattern Adverse events collection
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 Hormone Replacement Therapy (HRT)
Locations and Contacts
Additional Information
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Starting date: September 2005
Last updated: December 11, 2008
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