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Menorrhagia Study in Women With Treatment-resistant Menorrhagia

Primary Purpose

Menorrhagia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Asoprisnil (BAY86-5294)
Asoprisnil (BAY86-5294)
Asoprisnil (BAY86-5294)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Treatment-resistant menorrhagia

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients with treatment-resistant menorrhagia scheduled for hysterectomy. Exclusion Criteria: Organic causes of menorrhagia Current hormone treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Description

    Outcomes

    Primary Outcome Measures

    Individual relative change in uterine bleeding scores by PBAC

    Secondary Outcome Measures

    Endometrial thickness
    Adverse events collection
    Bleeding pattern
    Endometrial histology incl. immunohistochemical evaluations

    Full Information

    First Posted
    February 7, 2006
    Last Updated
    December 29, 2014
    Sponsor
    Bayer
    Collaborators
    TAP Pharmaceutical Products Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00288691
    Brief Title
    Menorrhagia Study in Women With Treatment-resistant Menorrhagia
    Official Title
    A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bayer
    Collaborators
    TAP Pharmaceutical Products Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menorrhagia
    Keywords
    Treatment-resistant menorrhagia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Title
    Arm 2
    Arm Type
    Experimental
    Arm Title
    Arm 3
    Arm Type
    Experimental
    Arm Title
    Arm 4
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil (BAY86-5294)
    Intervention Description
    5mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil (BAY86-5294)
    Intervention Description
    10mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil (BAY86-5294)
    Intervention Description
    25mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Individual relative change in uterine bleeding scores by PBAC
    Time Frame
    Pretreatment cycle treatment phase
    Secondary Outcome Measure Information:
    Title
    Endometrial thickness
    Time Frame
    End of treatment
    Title
    Adverse events collection
    Time Frame
    Whole treatment period
    Title
    Bleeding pattern
    Time Frame
    Treatment period
    Title
    Endometrial histology incl. immunohistochemical evaluations
    Time Frame
    End of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with treatment-resistant menorrhagia scheduled for hysterectomy. Exclusion Criteria: Organic causes of menorrhagia Current hormone treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Menorrhagia Study in Women With Treatment-resistant Menorrhagia

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