We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Menorrhagia Study in Women With Treatment-resistant Menorrhagia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288691
First Posted: February 8, 2006
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by:
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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: 26
Study Start Date: November 2001
Study Completion Date: January 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288691


Sponsors and Collaborators
Bayer
TAP Pharmaceutical Products Inc.
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00288691     History of Changes
Other Study ID Numbers: 90955
304667
First Submitted: February 7, 2006
First Posted: February 8, 2006
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Treatment-resistant menorrhagia

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