Trial Condition(s):

Vasomotor Symptoms

Safety/efficacy study of drospirenone/estradiol to treat postmenopausal Chinese women with vasomotor symptoms.

Bayer Identifier:

91442

ClinicalTrials.gov Identifier:

NCT00356447

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
249
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Peking Union Medical College Hospital

Beijing, China, 100730

Status
Completed
 
Locations

Obstetrics & Gynecology Hosp. of Fudan Univ.

Shanghai, China, 200011

Status
Completed
 
Locations

2nd Hosp., Chongqing Medical Univ.

Chongqing, China, 400010

Status
Completed
 
Locations

1st Affiliated Hosp., of Nanjing Medical Univ.

Nanjing, China, 210029

Status
Completed
 
Locations

Peking Univ. First Hosp.

Beijing, China, 100034

Status
Completed
 
Locations

Peking University Third Hospital

Beijing, China, 100083

Status
Completed
 
Locations

Respiratory Diseases Institute, Beijing Chaoyang Hospital

Beijing, China, 100020

Status
Completed
 
Locations

Qilu Hosp., Shandong Univ.

Jinan, China, 250012

Status
Completed
 
Locations

Union hospital of Tongji Medical College,Huazhong university

Wuhan, China, 430032

Status
Completed
 

Trial Design