A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
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)
2 other identifiers
interventional
460
7 countries
13
Brief Summary
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2007
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
November 30, 2009
CompletedSeptember 8, 2014
September 1, 2014
1.3 years
March 27, 2007
September 1, 2009
September 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.
7 - 14 days after completion of study drug therapy
Secondary Outcomes (10)
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
7 - 14 days after completion of study drug therapy
Clinical Response on Treatment for Per Protocol Population
4 - 7 days after start of therapy
Clinical Response on Treatment for Intent To Treat Population
4 - 7 days after start of therapy
Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
7 - 14 days at TOC visit
Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
7 - 14 days at TOC visit
- +5 more secondary outcomes
Study Arms (2)
Moxifloxacin
EXPERIMENTALMoxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin plus Metronidazole
ACTIVE COMPARATORLevofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Interventions
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Eligibility Criteria
You may qualify if:
- Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.
You may not qualify if:
- Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (13)
Unknown Facility
Shenyang, Liaoning, 110004, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Beijing, 100034, China
Unknown Facility
Beijing, 100083, China
Unknown Facility
Chongqing, 400010, China
Unknown Facility
Shanghai, 200011, China
Unknown Facility
Jakarta, Indonesia
Unknown Facility
Karachi, Pakistan
Unknown Facility
Manila, Philippines
Unknown Facility
Seoul, 133792, South Korea
Unknown Facility
Taipei, Taiwan, 10002, Taiwan
Unknown Facility
Taizung, 402, Taiwan
Unknown Facility
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 20716255RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Out of the 460 randomized subjects, 5 subjects (3 moxifloxacin subjects, 2 placebo subjects) did not receive any study medication. Only one of these patients had an adverse event (stomachache, randomized to Moxifloxacin).
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2007
First Posted
March 28, 2007
Study Start
January 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
September 8, 2014
Results First Posted
November 30, 2009
Record last verified: 2014-09