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

NCT ID: NCT00185237

Last Updated: 2014-12-23

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

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Hot Flashes

Keywords

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Menostar (estradiol transdermal delivery system)

Intervention Type DRUG

Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo patch

Interventions

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Menostar (estradiol transdermal delivery system)

Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Intervention Type DRUG

Placebo

Placebo patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence of postmenopausal status

Exclusion Criteria

* Contraindication to estrogen therapy
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

Countries

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Hong Kong Malaysia Philippines Singapore Thailand

Other Identifiers

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309120

Identifier Type: -

Identifier Source: secondary_id

91441

Identifier Type: -

Identifier Source: org_study_id