A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

Phase 3 Completed 460 enrolled Bayer

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)

Timeline

Start: 2007-01
Primary completion: 2008-05
Completion: 2008-05

Outcome

Met primary endpoint

paper moxifloxacin was noninferior to levofloxacin plus metronidazole (moxifloxacin: 152/194, 78.4%; comparator 155/190, 81.6%; 95% CI -10.7 to +4.9). PMID 20716255 ↗

Publications

Results Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Levofloxacin	Small molecule	500 mg	Oral
Comparator	Metronidazole	Small molecule	500 mg	Oral
Subject	Moxifloxacin	Small molecule	400 mg	Oral