A prospective, open-label, single-arm, multicenter study to evaluate the efficacy, safety and tolerability of CDB-2914 [ulipristal] as emergency contraception when taken between 48 hours and 120 hours of unprotected sex

Trial Profile

A prospective, open-label, single-arm, multicenter study to evaluate the efficacy, safety and tolerability of CDB-2914 [ulipristal] as emergency contraception when taken between 48 hours and 120 hours of unprotected sex

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2010

At a glance

  • Drugs Ulipristal (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 13 Aug 2010 According to a company media release, Watson Pharmaceuticals plans to launch Ella [ulipristal] as an emergency contraceptive in the fourth quater of 2010.
    • 13 Aug 2010 According to an HRA Pharma media release, the US FDA has granted approval for ulipristal as a prescription-only emergency contraceptive, based on results of this and another phase III trial (CTP 700022221).
    • 21 Apr 2008 Status change from recruiting to completed, according to clinicaltrials.gov.
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