A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Estradiol (Primary)
  • Indications Atrophic vaginitis; Dyspareunia
  • Focus Registrational; Therapeutic Use
  • Acronyms REJOICE
  • Sponsors TherapeuticsMD
  • Most Recent Events

    • 05 Oct 2017 According to a TherapeuticsMD media release, data from the study will be presented at the annual meeting of the North American Menopause Society (NAMS) 2017.
    • 14 Sep 2017 According to a TherapeuticsMD media release, the Company has scheduled a formal meeting with the FDA for 3 Nov 2017, at which the Company expects to learn if the submitted additional endometrial safety data addresses the lack of long-term safety identified in the Complete Response Letter for the NDA for TX-004HR and plans to re-submit the NDA for TX-004HR shortly after the meeting.
    • 14 Sep 2017 According to a TherapeuticsMD media release, the company has submitted the additional endometrial safety data that was requested by the FDA in its recent General Advice Letter to the Company to the New Drug Application (NDA) for TX-004HR and includes a comprehensive, systematic review of the medical literature, including the safety data from the recently published Womens Health Initiative Observational Study of vaginal estrogen use in postmenopausal women.
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