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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Investigate the Efficacy, Safety, and Tolerability of 3 doses of SPK 0602 (pentamycin) Vaginal Tablets vs Placebo (vehicle) in Patients with Symptomatic Vaginitis due to Bacterial Vaginosis, Candidiasis or Trichomoniasis.

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Investigate the Efficacy, Safety, and Tolerability of 3 doses of SPK 0602 (pentamycin) Vaginal Tablets vs Placebo (vehicle) in Patients with Symptomatic Vaginitis due to Bacterial Vaginosis, Candidiasis or Trichomoniasis.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Feb 2013

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At a glance

  • Drugs Pentamycin (Primary)
  • Indications Bacterial vaginosis; Candidiasis; Trichomoniasis; Vaginitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Lumavita

Most Recent Events

  • 19 Aug 2011 EudraCT2007-007659-15 identified as trial registry record, and multiple details added
  • 19 Aug 2011 Planned number of patients changed to 484.
  • 03 Mar 2010 Status changed from recruiting to completed, as reported in the EudraCT profile

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