Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

December 30, 2014 updated by: Bayer

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle

Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 135-710

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal Korean women suffering from hot flushes

Exclusion Criteria:

  • Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
PLACEBO_COMPARATOR: Arm 2
Drug: Placebo
Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hot flush (frequency and severity)
Time Frame: Daily in pre-treatment and treatment period
Daily in pre-treatment and treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Menopausal symptoms
Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Urogenital symptoms
Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Assessment of bleeding
Time Frame: daily in pre-treatment and treatment period
daily in pre-treatment and treatment 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

July 1, 2004

Study Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (ESTIMATE)

April 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91354
  • 308381

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.

Subscribe