CClinicalTrials.gg
CompletedNCT00683865MAIDENUpdated Oct 15, 2014

Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

A Phase 3 interventional study of Ofloxacin and Avelox (Moxifloxacin, BAY12-8039) in Pelvic Inflammatory Disease, sponsored by Bayer. Completed at 77 sites in 13 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
749
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

02

Conditions studied

  • Pelvic Inflammatory Disease

Keywords

  • Antibiotic treatment
  • Pelvic infection
  • Interventional study
  • Female
03

In context

Pelvic Inflammatory Disease

37 studies on the registry are indexed under Pelvic Inflammatory Disease; 5 are open to participants now.

This study's enrollment of 749 is above the median of 163 across 30 interventional studies indexed under Pelvic Inflammatory Disease.

Browse Pelvic Inflammatory Disease studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Pregnancy
  • Abnormal lab values
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
749 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Drug: Ofloxacin

  • Experimental
    Arm 2

    Drug: Avelox (Moxifloxacin, BAY12-8039)

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

06

What researchers measure

Primary outcomes

  1. Clinical response 5 to 24 days after the last dose of study medication

    Time frame: 5 to 24 days after the last dose

Secondary outcomes

  1. 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

  2. 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

  3. Reduction from baseline in pain report at the different assessment visits

    Time frame: Over the entire trial period (overall)

  4. 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)

07

Study locations

77 sites
  • Hvidovre, 2650, Denmark
  • Odense C, DK-5000, Denmark
  • Roskilde, DK-4000, Denmark
  • Helsinki, 00029, Finland
  • Hämeenlinna, 13530, Finland
  • Joensuu, 80210, Finland
  • Kotka, 48210, Finland
  • Antony Cedex, 92166, France
  • Beaumont, 63110, France
  • Bordeaux, 33000, France
  • Brive-la-gaillarde, 19100, France
  • Cenon, 33150, France
  • Colombes Cedex, 92701, France
  • Creteil Cedex, 94010, France
  • Domont, 95330, France
  • Lille, 59037, France
  • Montauban, 82000, France
  • Montpellier, 34059, France
  • Muret, 31600, France
  • Nancy Cedex, 54045, France
  • Paris, 75009, France
  • Paris, 75020, France
  • Toulouse, 31059, France
  • München, Bayern 80336, Germany
  • Rostock, Mecklenburg-Vorpommern 18057, Germany
  • Essen, Nordrhein-Westfalen 45257, Germany
  • Grevenbroich, Nordrhein-Westfalen 41515, Germany
  • Leverkusen, Nordrhein-Westfalen 51375, Germany
  • Wuppertal, Nordrhein-Westfalen 42103, Germany
  • Berlin, 10117, Germany
  • Berlin, 10249, Germany
  • Athens, Attica 115 21, Greece
  • Athens, Attica 11528, Greece
  • Dourouti-Ioannina, Ioannina 45500, Greece
  • Budapest, 1115, Hungary
  • Budapest, H-1085, Hungary
  • Eger, 3301, Hungary
  • Györ, 9024, Hungary
  • Kecskemet, 6000, Hungary
  • Pavia, 27100, Italy
  • Perugia, 06122, Italy
  • Trieste, 34137, Italy
  • Klaipeda, 92288, Lithuania
  • Vilnius, LT-04130, Lithuania
  • Vilnius, LT-2000, Lithuania
  • Vilnius, LT-2021, Lithuania
  • Bialystok, 15-276, Poland
  • Krakow, 30-501, Poland
  • Lodz, 93-338, Poland
  • Lublin, 20-090, Poland
  • Owock, 05-400, Poland
  • Poznan, 61-701, Poland
  • Warszawa, 00-416, Poland
  • Warszawa, 00-909, Poland
  • Moscow, 107076, Russian Federation
  • Moscow, 117049, Russian Federation
  • Moscow, 117997, Russian Federation
  • Bloemfontein, Free State 9300, South Africa
  • Johannesburg, Gauteng 1804, South Africa
  • Johannesburg, Gauteng 2132, South Africa
  • Pretoria, Gauteng 0001, South Africa
  • Pretoria, Gauteng, South Africa
  • Durban, KwaZulu Natal 4001, South Africa
  • Cape Town, Western Cape 7505, South Africa
  • Cape Town, Western Cape, South Africa
  • Göteborg, 413 45, Sweden
  • Linköping, 581 85, Sweden
  • Lund, 221 85, Sweden
  • Trollhättan, 461 85, Sweden
  • Varberg, 432 81, Sweden
  • Bristol, Avon BS2 8HW, United Kingdom
  • London, Greater London SW10 9NH, United Kingdom
  • London, Greater London SW17 0QT, United Kingdom
  • London, Greater London WC1E 6AU, United Kingdom
  • Southampton, Hampshire SO14 0YG, United Kingdom
  • Nottingham, Nottinghamshire NG5 1PB, United Kingdom
  • Birmingham, West Midlands B4 6DH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00683865
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
May 26, 2008
Start date
Apr 2003
Primary completion
Oct 2004
Completion
Oct 2004
Last update
Oct 15, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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