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Menorrhagia Study in Women With Treatment-resistant Menorrhagia

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ClinicalTrials.gov Identifier: NCT00288691
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : December 30, 2014
TAP Pharmaceutical Products Inc.
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Menorrhagia Drug: Asoprisnil (BAY86-5294) Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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
Study Start Date : November 2001
Study Completion Date : January 2004

Arm Intervention/treatment
Experimental: Arm 1 Drug: Asoprisnil (BAY86-5294)
Experimental: Arm 2 Drug: Asoprisnil (BAY86-5294)
Experimental: Arm 3 Drug: Asoprisnil (BAY86-5294)
Placebo Comparator: Arm 4 Drug: Placebo

Primary Outcome Measures :
  1. Individual relative change in uterine bleeding scores by PBAC [ Time Frame: Pretreatment cycle treatment phase ]

Secondary Outcome Measures :
  1. Endometrial thickness [ Time Frame: End of treatment ]
  2. Adverse events collection [ Time Frame: Whole treatment period ]
  3. Bleeding pattern [ Time Frame: Treatment period ]
  4. Endometrial histology incl. immunohistochemical evaluations [ Time Frame: End of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

  • Organic causes of menorrhagia
  • Current hormone treatment

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
TAP Pharmaceutical Products Inc.
Study Director: Bayer Study Director Bayer

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

Keywords provided by Bayer:
Treatment-resistant menorrhagia

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