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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
249
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.
Same administration.
Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Jinan, Shandong, China
Unnamed facility
Beijing, China
Frequency of hot flushes
Time frame: From baseline to week 16
Change in intensity of hot flushes
Time frame: From baseline to week 16
Change in other climacteric symptoms
Time frame: From baseline to week 16
Vaginal Bleeding pattern
Time frame: From baseline to week 16
Global clinical impression
Time frame: From baseline to week 16
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Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Chongqing, China
Unnamed facility
Shanghai, China