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: 03 Aug 2017

At a glance

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

    • 03 Aug 2017 According to a TherapeuticsMD media release, the company has submitted additional information for consideration related to the NDA for TX-004HR. The FDA's timing of review of the submitted additional data will be communicaed to TherapeuticsMD through an Advice Letter.
    • 08 May 2017 According to a company media release, TherapeuticsMD has received a CRL from the US FDA regarding the NDA for TX-004HR. In the CRL, the only approvability concern raised by the FDA was the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in this trial. The CRL did not identify any issues related to the efficacy of TX-004HR and did not identify any approvability issues related to chemistry, manufacturing, and controls.
    • 19 Apr 2017 According to a TherapeuticsMD media release, the FDA will finalize an action on the NDA, including informing the Company of the deficiencies in the NDA identified by the FDA, on or before the originally scheduled PDUFA target action date of May 7, 2017.
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