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3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

NCT ID: NCT00310531

Last Updated: 2014-12-30

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-06-30

Brief Summary

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The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.

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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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Menostar (Estradiol, BAY86-5435)

Intervention Type DRUG

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

Arm 2

Group Type ACTIVE_COMPARATOR

Raloxifene

Intervention Type DRUG

Raloxifene tbl. (60 mg/day)

Interventions

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Menostar (Estradiol, BAY86-5435)

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

Intervention Type DRUG

Raloxifene

Raloxifene tbl. (60 mg/day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Last (regular) menstrual period more than 5 years ago
* Relative good state of health
* Intact, normal uterus

Exclusion Criteria

* Bone and musculoskeletal diseases
* Clinically significant vertebral fracture within the last 12 months
* Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
* Uncontrolled diabetes mellitus (or treated with insulin)
* Uncontrolled thyroid disorders
* Relevant renal disorder or significant liver dysfunction (including cholestasis)
* History of alcohol or drug abuse
* History of immobilization of more than 2 months in the last 6 months
* Smoking of more than 10 cigarettes per day
* Unexplained uterine bleeding
* Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 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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United States

Other Identifiers

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306871

Identifier Type: -

Identifier Source: secondary_id

91213

Identifier Type: -

Identifier Source: org_study_id