Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

November 7, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Relative change in frequency of hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Relative change from baseline to Week 12 in frequency of hot flushes

Change History

Complete list of historical versions of study NCT00185237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in intensity of hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in vaginal maturation index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Occurrence of urogenital symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in MENQOL (menopausal quality of life questionaire) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Bleeding profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

- Effects on futher climacteric symptoms, e.g. vaginal atrophy.
- Quality of Life
- Bleeding pattern

Descriptive Information

Brief Title ^ICMJE

Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch

Official Title ^ICMJE

A Multicenter, Double-Blind, Randomized, Placebo Controlled Study on the Effect of Ultra-Low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-Being in Postmenopausal Asian Women Over 12 Weeks.

Brief Summary

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany 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

Hot Flashes

Intervention ^ICMJE

Drug: Menostar (estradiol transdermal delivery system)
Drug: Placebo

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

283

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Evidence of postmenopausal status

Exclusion Criteria:

Contraindication to estrogen therapy

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00185237

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study ID Numbers ^ICMJE

91441, 309120

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