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: 26 Mar 2018

At a glance

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

    • 26 Mar 2018 According to an AMAG Pharmaceuticals media release, based on the data from two Phase 3 trials (this and CTP 253197), the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women in February 2017.
    • 27 Feb 2017 Results published in an AMAG Pharmaceuticals media release.
    • 27 Feb 2017 According to an AMAG Pharmaceuticals media release, additional results from the study were presented at the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting.
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