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

NCT00356447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2014-10-01

No results posted yet for this study

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-genital complaints.

Conditions

Interventions

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.

DRUG

Placebo

Same administration.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356447 on ClinicalTrials.gov