Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Phase 3

Completed

• Conditions: Vasomotor Symptoms
• Interventions: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Drug: Placebo

• Registration Number: NCT00651599
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study Completion: 2005-05
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Postmenopausal Korean women suffering from hot flushes

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Exclusion Criteria

• Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Hot flush (frequency and severity)	Daily in pre-treatment and treatment period

Secondary Outcome Measures

Name	Time	Method
Urogenital symptoms	Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Assessment of bleeding	daily in pre-treatment and treatment period
Menopausal symptoms	Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment