Menorrhagia Study in Women With Treatment-Resistant Menorrhagia

This study has been completed.
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00288691
First received: February 7, 2006
Last updated: December 11, 2008
Last verified: December 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Experimental: Arm 1 Drug: Asoprisnil (BAY86-5294)
5mg/day
Experimental: Arm 2 Drug: Asoprisnil (BAY86-5294)
10mg/day
Experimental: Arm 3 Drug: Asoprisnil (BAY86-5294)
25mg/day
Placebo Comparator: Arm 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Keywords provided by Bayer:
Treatment-resistant menorrhagia

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014