A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women.

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women.

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jan 2013

At a glance

  • Drugs Testosterone (Primary)
  • Indications Decreased libido; Female sexual dysfunction
  • Focus Adverse reactions; Registrational
  • Acronyms BLISS; BLOOM
  • Most Recent Events

    • 06 Oct 2012 Results presented at the 23rd Annual Meeting of the North American Menopause Society.
    • 04 Sep 2012 Status changed from active, no longer recruiting to completed (following the the ninth unblinded review by the independent Data Monitoring Committee).
    • 09 Feb 2012 Study to continue without modifications due to positive tolerability outcomes reported by the eight unblinded review of the independent Data Monitoring Committee, according to a BioSante Pharmaceuticals media release
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