Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin. (MAIDEN)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: May 21, 2008
Last updated: October 12, 2014
Last verified: October 2014
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Condition Intervention Phase
Pelvic Inflammatory Disease
Drug: Ofloxacin
Drug: Avelox (Moxifloxacin, BAY12-8039)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical response 5 to 24 days after the last dose of study medication [ Time Frame: 5 to 24 days after the last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication [ Time Frame: visit 28 to 42 days after last dose ] [ Designated as safety issue: No ]
  • Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose [ Time Frame: (Day 4-7) and at follow-up 28 to 42 days after last dose ] [ Designated as safety issue: No ]
  • Reduction from baseline in pain report at the different assessment visits [ Time Frame: Over the entire trial period (overall) ] [ Designated as safety issue: No ]
  • Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up [ Time Frame: Over the entire trial period (overall) ] [ Designated as safety issue: No ]

Enrollment: 749
Study Start Date: April 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Ofloxacin
Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Experimental: Arm 2 Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg po od for 14 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683865

  Show 77 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00683865     History of Changes
Other Study ID Numbers: 10995 
Study First Received: May 21, 2008
Last Updated: October 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Ethics Committee
Finland: Ethics Committee
France: Ministry of Health
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health
Sweden: Regional Ethical Review Board
South Africa: National Health Research Ethics Council
Russia: Ethics Committee

Keywords provided by Bayer:
Antibiotic treatment
Pelvic infection
Interventional study

Additional relevant MeSH terms:
Pelvic Infection
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Renal Agents
Reproductive Control Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016