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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00453349
• Date of registration: 27/03/2007
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
• Scientific title: 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)
• Date of first enrolment: January 2007
• Target sample size: 460
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00453349
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

China, Indonesia, Korea, Republic of, Pakistan, Philippines, Taiwan, Thailand

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess
at pelvic ultrasound and/or laparoscopic examination.

Exclusion Criteria:

- Subjects with impaired liver and renal function; known hypersensitivity to study
drugs, related compounds or any of the excipients.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic Inflammatory Disease

Intervention(s)

Drug: Moxifloxacin (Avelox, BAY12-8039)

Drug: Levofloxacin & Metronidazole

Primary Outcome(s)

Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population [Time Frame: 7 - 14 days after completion of study drug therapy]

Secondary Outcome(s)

Clinical Response at Follow-up Visit on Intent To Treat Population [Time Frame: 28 - 42 days after completion of study drug therapy]

Clinical Response at Follow-up Visit on Per Protocol Population [Time Frame: 28 - 42 days after completion of study drug therapy]

Clinical Response on Treatment for Per Protocol Population [Time Frame: 4 - 7 days after start of therapy]

Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism [Time Frame: 28 - 42 days after completion of study drug therapy]

Bacteriological Response at Follow-up Visit Microbiologically Valid [Time Frame: 28 - 42 days after completion of study drug therapy]

Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism [Time Frame: 7 - 14 days at TOC visit]

Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population [Time Frame: 7 - 14 days after completion of study drug therapy]

Clinical Response on Treatment for Intent To Treat Population [Time Frame: 4 - 7 days after start of therapy]

Number of Subjects Who Received Alternative Medicine [Time Frame: Up to 42 days after end of treatment]

Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid [Time Frame: 7 - 14 days at TOC visit]

Secondary ID(s)

2006-000874-56

11981

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/11/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00453349