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

Bayer

Status and phase: Completed; Phase 3

Conditions: Pelvic Inflammatory Disease

Treatments: Drug: Moxifloxacin (Avelox, BAY12-8039); Drug: Levofloxacin & Metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00453349

11981

2006-000874-56 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 460 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups

Moxifloxacin

Experimental group

Description:

Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days

Treatment:

Drug: Moxifloxacin (Avelox, BAY12-8039)

Levofloxacin plus Metronidazole

Active Comparator group

Description:

Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Treatment:

Drug: Levofloxacin & Metronidazole