A multicenter, double-blind, randomized, parallel-group, placebo controlled, 7 cycle duration of oral SH T00658ID [estradiol valerate/dienogest] tablets for the treatment of dysfunctional uterine bleeding.

Trial Profile

A multicenter, double-blind, randomized, parallel-group, placebo controlled, 7 cycle duration of oral SH T00658ID [estradiol valerate/dienogest] tablets for the treatment of dysfunctional uterine bleeding.

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2013

At a glance

  • Drugs Estradiol valerate/dienogest (Primary)
  • Indications Menorrhagia
  • Focus Registrational; Therapeutic Use
  • Sponsors Bayer; Berlex Inc
  • Most Recent Events

    • 10 Jan 2012 Results of a pooled analysis (CTPs 13663 and 16199) published in Contraception.
    • 20 Oct 2009 Results were presented at ASRM 2009.
    • 28 Sep 2008 Actual end date changed from Feb 2007 to May 2008 as reported by CT.gov
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