Status:

COMPLETED

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

Lead Sponsor:

Bayer

Conditions:

Vasomotor Symptoms

Eligibility:

FEMALE

45-65 years

Phase:

PHASE3

Brief Summary

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...

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.

Eligibility Criteria

Inclusion

  • Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion

  • 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

Key Trial Info

Start Date :

May 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

249 Patients enrolled

Trial Details

Trial ID

NCT00356447

Start Date

May 1 2006

End Date

October 1 2007

Last Update

October 1 2014

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Wuhan, Hubei, China, 430032

2

Nanjing, Jiangsu, China, 210029

3

Jinan, Shandong, China, 250012

4

Beijing, China, 100020