Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

September 30, 2014 updated by: Bayer

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

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 HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Study Type

Interventional

Enrollment (Actual)

249

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

  • China
      • Beijing, China, 100730
      • Beijing, China, 100020
      • Beijing, China, 100083
      • Beijing, China, 100034
      • Chongqing, China, 400010
      • Shanghai, China, 200011
    • Hubei
      • Wuhan, Hubei, China, 430032
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
    • Shandong
      • Jinan, Shandong, China, 250012

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:

  • Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion Criteria:

  • History of steroid hormone dependent malignant disease
  • Known or suspected malignant or premalignant disease
  • Current or history of severe heart, liver, renal, psychiatric disease
  • Hyperlipemia

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 2
Drug: Placebo
Same administration.
Active Comparator: Arm 1
Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of hot flushes
Time Frame: From baseline to week 16
From baseline to week 16
Change in intensity of hot flushes
Time Frame: From baseline to week 16
From baseline to week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in other climacteric symptoms
Time Frame: From baseline to week 16
From baseline to week 16
Vaginal Bleeding pattern
Time Frame: From baseline to week 16
From baseline to week 16
Global clinical impression
Time Frame: From baseline to week 16
From baseline to week 16

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

May 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91442
  • 309341 (Other Identifier: Company internal)

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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