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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 flushes

The 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

Page last updated: August 23, 2015

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