Phase 3 N=460 Randomized Double-blind Treatment

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

Pelvic Inflammatory Disease

Bottom Line

View on ClinicalTrials.gov: NCT00453349 ↗

Enrolled (actual)

460

Serious AEs

0.9%

Results posted

Nov 2009

Primary outcome: Primary: Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population — 152; 155; 42; 35 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Moxifloxacin (Avelox, BAY12-8039) (Drug); Levofloxacin & Metronidazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population	152; 155; 42; 35	—
SECONDARY Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population	163; 171; 62; 59	—
SECONDARY Clinical Response on Treatment for Per Protocol Population	177; 181; 11; 5	—
SECONDARY Clinical Response on Treatment for Intent To Treat Population	166; 170; 59; 60	—
SECONDARY Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid	27; 22; 3; 4	—
SECONDARY Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism	28; 25; 8; 9	—
SECONDARY Clinical Response at Follow-up Visit on Per Protocol Population	157; 158; 27; 22	—
SECONDARY Clinical Response at Follow-up Visit on Intent To Treat Population	166; 170; 59; 60	—
SECONDARY Bacteriological Response at Follow-up Visit Microbiologically Valid	23; 22; 5; 4	—
SECONDARY Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism	23; 23; 13; 11	—
SECONDARY Number of Subjects Who Received Alternative Medicine	4; 1; 190; 189	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00453349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.