A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

Trial Profile

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2015

At a glance

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

    • 09 Jul 2015 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
    • 04 Dec 2014 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
    • 04 Apr 2014 Planned End Date changed from 1 Jan 2015 to 1 Aug 2015 as reported by ClinicalTrials.gov.
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