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.
Phase of Trial: Phase II
Latest Information Update: 23 Feb 2013
At a glance
- Drugs Pentamycin (Primary)
- Indications Bacterial vaginosis; Candidiasis; Trichomoniasis; Vaginitis
- Focus Registrational; Therapeutic Use
- Sponsors Lumavita
- 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