A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms.

Trial Profile

A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Mar 2017

At a glance

  • Drugs Estradiol (Primary)
  • Indications Atrophic vaginitis
  • Focus Adverse reactions; Registrational
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 03 Jul 2012 Planned number of patients changed from 325 to 530 as reported by European Clinical Trials Database.
    • 01 Dec 2008 Actual patient number reported as 335 by ClinicalTrials.gov.
    • 01 Dec 2008 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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