Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

NCT ID: NCT00651599

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-05-31

Brief Summary

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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

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Conditions

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Vasomotor Symptoms

Keywords

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Vasomotor symptoms Vasomotor System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Arm 1

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal Korean women suffering from hot flushes
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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308381

Identifier Type: -

Identifier Source: secondary_id

91354

Identifier Type: -

Identifier Source: org_study_id