Treatment of Vasomotor Symptoms in Korean Post Menopausal Women - Tabular View

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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

This study has been completed.

Study NCT00651599. Last updated on April 2, 2008. Information provided by Bayer

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Official Title ^†

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle

Brief Summary

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

Safety and tolerability of Angeliq®.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Hot flush (frequency and severity) [ Time Frame: Daily in pre-treatment and treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Menopausal symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ] [ Designated as safety issue: No ]
Urogenital symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ] [ Designated as safety issue: No ]
Assessment of bleeding [ Time Frame: daily in pre-treatment and treatment period ] [ Designated as safety issue: No ]

Condition ^†

Vasomotor Symptoms

Intervention ^†

Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol)
Drug: Placebo

MEDLINE PMIDs

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Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

July 2004

Completion Date

May 2005

Eligibility Criteria ^†

Inclusion Criteria:

Postmenopausal Korean women suffering from hot flushes

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.

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Korea, Republic of

Administrative Information Fields

NCT ID ^†

NCT00651599

Organization ID

91354

Secondary IDs ^††

308381

Study Sponsor ^†

Bayer

Collaborators ^††

Investigators ^†

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2008

First Received Date ^†

April 1, 2008

Last Updated Date

April 2, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.