Clinical Trial: Menorrhagia Study in Women With Treatment-resistant Menorrhagia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Men
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 Summary: 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.
Sponsor: Bayer
Current Primary Outcome: Individual relative change in uterine bleeding scores by PBAC [ Time Frame: Pretreatment cycle treatment phase ]
Original Primary Outcome: Individual relative change in uterine bleeding scores by PBAC
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Endometrial thickness, Adverse events
Information By: Bayer
Dates:
Date Received: February 7, 2006
Date Started: November 2001
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014
