Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Trial Profile

Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2018

At a glance

  • Drugs Bremelanotide (Primary)
  • Indications Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Acronyms RECONNECT
  • Sponsors Palatin Technologies
  • Most Recent Events

    • 04 Jun 2018 According to an AMAG Pharmaceuticals media release, the Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the bremelanotide NDA is March 23, 2019.
    • 04 Jun 2018 According to an AMAG Pharmaceuticals media release, based on the data from two Phase 3 trials (this and CTP 214406), the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for bremelanotide to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
    • 30 Apr 2018 Results (n=242) presenting outcomes from exit surveys completed by a subset of subjects presented at the 66th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists
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