Menorrhagia Study in Women With Treatment-Resistant Menorrhagia - Full Text View

Sponsors and Collaborators:	Bayer TAP Pharmaceutical Products Inc.
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00288691

Purpose

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

Condition	Intervention	Phase
Menorrhagia	Drug: Asoprisnil (BAY86-5294) Drug: Placebo	Phase II

Drug Information available for: Asoprisnil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Individual relative change in uterine bleeding scores by PBAC [ Time Frame: Pretreatment cycle treatment phase ]

Secondary Outcome Measures:

Endometrial thickness [ Time Frame: End of treatment ]
Adverse events collection [ Time Frame: Whole treatment period ]
Bleeding pattern [ Time Frame: Treatment period ]
Endometrial histology incl. immunohistochemical evaluations [ Time Frame: End of treatment ]

Enrollment:	40
Study Start Date:	November 2001
Study Completion Date:	February 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Asoprisnil (BAY86-5294) 5mg/day
Arm 2: Experimental	Drug: Asoprisnil (BAY86-5294) 10mg/day
Arm 3: Experimental	Drug: Asoprisnil (BAY86-5294) 25mg/day
Arm 4: Placebo Comparator	Drug: Placebo Placebo

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.

Eligibility

Ages Eligible for Study:	30 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

Organic causes of menorrhagia
Current hormone treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288691

Sponsors and Collaborators

Bayer

TAP Pharmaceutical Products Inc.

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	90955, 304667
Study First Received:	February 7, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00288691 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:

Treatment-resistant menorrhagia

Study placed in the following topic categories:

Genital Diseases, Female
Menstruation Disturbances
Uterine Hemorrhage

Uterine Diseases
Menorrhagia
Hemorrhage

Additional relevant MeSH terms:

Genital Diseases, Female
Pathologic Processes
Menstruation Disturbances

Uterine Hemorrhage
Uterine Diseases
Menorrhagia

ClinicalTrials.gov processed this record on May 07, 2009