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Menorrhagia Study in Women With Treatment-resistant Menorrhagia

NCT ID: NCT00288691

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

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2004-01-31

Brief Summary

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The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.

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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Menorrhagia

Keywords

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Treatment-resistant menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Asoprisnil (BAY86-5294)

Intervention Type DRUG

5mg/day

Arm 2

Group Type EXPERIMENTAL

Asoprisnil (BAY86-5294)

Intervention Type DRUG

10mg/day

Arm 3

Group Type EXPERIMENTAL

Asoprisnil (BAY86-5294)

Intervention Type DRUG

25mg/day

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Asoprisnil (BAY86-5294)

5mg/day

Intervention Type DRUG

Asoprisnil (BAY86-5294)

10mg/day

Intervention Type DRUG

Asoprisnil (BAY86-5294)

25mg/day

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria

* Organic causes of menorrhagia
* Current hormone treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TAP Pharmaceutical Products Inc.

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Countries

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United Kingdom

Other Identifiers

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304667

Identifier Type: -

Identifier Source: secondary_id

90955

Identifier Type: -

Identifier Source: org_study_id