Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683865

Acronym

MAIDEN

Enrollment

749

Registered

2008-05-26

Start date

2003-04-30

Completion date

2004-10-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Inflammatory Disease

Keywords

Antibiotic treatment, Pelvic infection, Interventional study, Female

Brief summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Interventions

DRUGOfloxacin

Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days

DRUGAvelox (Moxifloxacin, BAY12-8039)

Moxifloxacin 400 mg po od for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness; * Adnexal tenderness on bimanual vaginal examination, * Temperature \> 38.0°C; - Elevated C-reactive protein value (CRP); * Signed PIC/IC

Exclusion criteria

* Pregnancy * Abnormal lab values

Design outcomes

Primary

Measure	Time frame
Clinical response 5 to 24 days after the last dose of study medication	5 to 24 days after the last dose

Secondary

Measure	Time frame
Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication	visit 28 to 42 days after last dose
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose	(Day 4-7) and at follow-up 28 to 42 days after last dose
Reduction from baseline in pain report at the different assessment visits	Over the entire trial period (overall)
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up	Over the entire trial period (overall)

Countries

Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Russia, South Africa, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026