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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

NCT00651599 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-12-31

No results posted yet for this study

Summary

Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

Conditions

Interventions

DRUG

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

DRUG

Placebo

Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-07-31
Completion
2005-05-31

Countries

  • South Korea

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 NCT00651599 on ClinicalTrials.gov