At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 enrolled
Drug / intervention
Moxifloxacin (Avelox, BAY12-8039) +1 moredrug
Likely dose
Moxifloxacin (Avelox, BAY12-8039) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double Dummy, Double Blind, Multi-center Multinational Trial Comparing the Efficacy and Safety of Moxifloxacin 400 mg PO QD 24 Hours for 14 Days to That of Levofloxacin 500 mg PO QD 24 Hours Plus Metronidazole 500 mg BID for 14 Days in Subjects With an Uncomplicated Pelvic Inflammatory Disease (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)
In Brief
A Phase 3 clinical trial evaluating Moxifloxacin (Avelox, BAY12-8039) and Levofloxacin & Metronidazole for Pelvic Inflammatory Disease. Completed, enrolled 460 participants across 13 sites in 7 countries.
Detailed Summary
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Inflammatory Disease
CountriesChina, Indonesia, Pakistan, Philippines, South Korea, Taiwan, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedMar 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedMar 28, 2007
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.3 years ago
Interventions
Moxifloxacin (Avelox, BAY12-8039)drug
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin & Metronidazoledrug
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days