Low-Dose Hormone Therapy for Relief of Vasomotor Symptoms - Tabular View

Tracking Information

First Received Date ^ICMJE

March 9, 2007

Last Updated Date

November 19, 2008

Start Date ^ICMJE

March 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change from baseline to Week 12 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Mean change from baseline to Week 12 in weekly frequency of moderate to severe hot flushes.
Mean change from baseline to Week 12 in weekly mean daily severity of moderate to severe hot flushes.
Mean change from baseline to Week 4 in weekly frequency of moderate to severe hot flushes.
Mean change from baseline to Week 4 in weekly mean daily severity of moderate to severe hot flushes.

Change History

Complete list of historical versions of study NCT00446199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean change from baseline to Week 12 in vaginal pH and vaginal maturation index [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Symptoms of vulvar and vaginal atrophy and urogenital symptoms at baseline and Week 12 [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Mean change from baseline to Week 12 in vaginal pH and vaginal maturation index
Symptoms of vulvar and vaginal atrophy and urogenital symptoms at baseline and Week 12.

Descriptive Information

Brief Title ^ICMJE

Low-Dose Hormone Therapy for Relief of Vasomotor Symptoms

Official Title ^ICMJE

A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Brief Summary

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vasomotor Symptoms
Hot Flashes

Intervention ^ICMJE

Drug: SH T546P
Drug: SH T04739CA and SH T04739BA
Drug: SH T04739DA

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

910

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Postmenopausal women > 40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria:

The usual exclusion criteria for hormone therapy apply.
Intake of medications other than hormones affecting hot flushes

Gender

Female

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00446199

Responsible Party

Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.

Study ID Numbers ^ICMJE

91493, 310184

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP