Efficacy and Tolerability of Angeliq in Thai Women

December 11, 2008 updated by: Bayer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women with hot flushes

Exclusion Criteria:

  • Women with a contraindication for Hormone Replacement Therapy (HRT)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The relative change in the frequency of hot flushes
Time Frame: At baseline, week 4, 8, 12
At baseline, week 4, 8, 12

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in intensity of hot flushes
Time Frame: At baseline, week 4, 8, 12
At baseline, week 4, 8, 12
The relative change in frequency of hot flushes
Time Frame: At baseline, week 4, 8
At baseline, week 4, 8
The change in intensity of hot flushes
Time Frame: At baseline, week 4, 8
At baseline, week 4, 8
The proportions of subjects with urogenital symptoms
Time Frame: At baseline, week 4, 8, 12
At baseline, week 4, 8, 12
Bleeding pattern
Time Frame: At baseline, week 4, 8, 12
At baseline, week 4, 8, 12
Adverse events collection
Time Frame: Collection of AE throughout the study period
Collection of AE throughout the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 12, 2008

Last Update Submitted That Met QC Criteria

December 11, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91436
  • 309367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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