Pivotal pharmacokinetic trial of a hormone therapy, TX 12001HR, for the treatment of menopausal syndrome.

Trial Profile

Pivotal pharmacokinetic trial of a hormone therapy, TX 12001HR, for the treatment of menopausal syndrome.

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Oct 2013

At a glance

  • Drugs Estradiol/progesterone (Primary) ; Estradiol; Progesterone
  • Indications Menopausal syndrome
  • Focus Pharmacokinetics; Registrational
  • Sponsors TherapeuticsMD
  • Most Recent Events

    • 12 Oct 2013 Primary endpoint 'Peak-drug-concentration' has been met according to results presented at the 24th Annual Meeting of the North American Menopause Society.
    • 12 Oct 2013 Primary endpoint 'Area-under-the-drug-concentration-time-curve' has been met according to results presented at the 24th Annual Meeting of the North American Menopause Society.
    • 09 Oct 2013 Results have been presented at The North American Menopause Society 2013 Annual Meeting according to a TherapeuticsMD media release. Results were also summarised in the media release.
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