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CompletedNCT00453349Updated Sep 8, 2014Results posted

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

A Phase 3 interventional study of Moxifloxacin (Avelox, BAY12-8039) and Levofloxacin & Metronidazole in Pelvic Inflammatory Disease, sponsored by Bayer. Completed at 13 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-08.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Pelvic Inflammatory Disease

Keywords

  • Uncomplicated pelvic inflammatory disease
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 460 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 uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.

Exclusion criteria

Exclusion Criteria:

  • Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
05

Study design

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

Study arms

  • Experimental
    Moxifloxacin

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

    Drug: Moxifloxacin (Avelox, BAY12-8039)

  • Active comparator
    Levofloxacin plus Metronidazole

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

    Drug: Levofloxacin & Metronidazole

Interventions

  • DrugMoxifloxacin (Avelox, BAY12-8039)

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

  • DrugLevofloxacin & Metronidazole

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

06

What researchers measure

Primary outcomes

  1. Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population

    Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.

    Time frame: 7 - 14 days after completion of study drug therapy

Secondary outcomes

  1. Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population

    For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".

    Time frame: 7 - 14 days after completion of study drug therapy

  2. Clinical Response on Treatment for Per Protocol Population

    At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by \>30% with improvement in temperature, clinical failure (reduction in severity score of \< or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).

    Time frame: 4 - 7 days after start of therapy

  3. Clinical Response on Treatment for Intent To Treat Population

    Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.

    Time frame: 4 - 7 days after start of therapy

  4. Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid

    The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.

    Time frame: 7 - 14 days at TOC visit

  5. Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism

    Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.

    Time frame: 7 - 14 days at TOC visit

  6. Clinical Response at Follow-up Visit on Per Protocol Population

    Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.

    Time frame: 28 - 42 days after completion of study drug therapy

  7. Clinical Response at Follow-up Visit on Intent To Treat Population

    All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.

    Time frame: 28 - 42 days after completion of study drug therapy

  8. Bacteriological Response at Follow-up Visit Microbiologically Valid

    Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.

    Time frame: 28 - 42 days after completion of study drug therapy

  9. Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism

    Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.

    Time frame: 28 - 42 days after completion of study drug therapy

  10. Number of Subjects Who Received Alternative Medicine

    As alternative medicine any systemic antibacterial medication was considered.

    Time frame: Up to 42 days after end of treatment

07

Results

Posted Nov 30, 2009
Limitations and caveats
Out of the 460 randomized subjects, 5 subjects (3 moxifloxacin subjects, 2 placebo subjects) did not receive any study medication. Only one of these patients had an adverse event (stomachache, randomized to Moxifloxacin).

Participant flow

A total of 463 females with uncomplicated PID were enrolled on the basis of a complete evaluation (interview, medical history and physical examination and laboratory tests). 460 subjects were randomized, 412 completed study treatment (whole medication), and 384 subjects were valid for the primary efficacy analysis.

Randomized
Participant flow — Randomized
MilestoneMoxifloxacinLevofloxacin Plus Metronidazole
Started228232
Completed203209
Not completed2523
Withdrew: Adverse event1211
Withdrew: Lack of efficacy21
Withdrew: Lost to follow-up75
Withdrew: Protocol violation11
Withdrew: Withdrawal by subject35
Reaching of Primary Endpoint (TOC)
Participant flow — Reaching of Primary Endpoint (TOC)
MilestoneMoxifloxacinLevofloxacin Plus Metronidazole
Started225230
Valid for primary efficacy analysis194190
Completed215219
Not completed1011
Withdrew: Missing information1011
Completed Study
Participant flow — Completed Study
MilestoneMoxifloxacinLevofloxacin Plus Metronidazole
Started228232
Completed study treatment203209
Completed201198
Not completed2734
Withdrew: Adverse event1211
Withdrew: Lack of efficacy21
Withdrew: Lost to follow-up75
Withdrew: Protocol violation11
Withdrew: Withdrawal by subject35
Withdrew: Lost to follow up after study treatment211

Outcome measures

PrimaryClinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population

Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.

Time frame:
7 - 14 days after completion of study drug therapy
Reported as:
Number · participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Clinical cure152155
Clinical non-success4235
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -3.2 · 95% CI -10.7 to 4.9Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryClinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population

For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".

Time frame:
7 - 14 days after completion of study drug therapy
Reported as:
Number · participants
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Clinical cure163171
Clinical non-success6259
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -1.9 · 95% CI -9.9 to 6.0Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryClinical Response on Treatment for Per Protocol Population

At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by \>30% with improvement in temperature, clinical failure (reduction in severity score of \< or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).

Time frame:
4 - 7 days after start of therapy
Reported as:
Number · participants
Clinical Response on Treatment for Per Protocol Population
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Clinical Improvement177181
Clinical failure115
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -3.2 · 95% CI -7.4 to 0.8Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryClinical Response on Treatment for Intent To Treat Population

Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.

Time frame:
4 - 7 days after start of therapy
Reported as:
Number · participants
Clinical Response on Treatment for Intent To Treat Population
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Clinical improvement166170
Failure, indeterminate, missing5960
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -0.1 · 95% CI -8.1 to 7.5Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryBacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid

The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.

Time frame:
7 - 14 days at TOC visit
Reported as:
Number · participants
Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Eradication2722
Persistence34
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): 5.4 · 95% CI -12.7 to 20.3Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryBacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism

Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.

Time frame:
7 - 14 days at TOC visit
Reported as:
Number · participants
Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Eradication2825
Persistence, indeterminate, missing89
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): 4.3 · 95% CI -19.4 to 17.6Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryClinical Response at Follow-up Visit on Per Protocol Population

Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.

Time frame:
28 - 42 days after completion of study drug therapy
Reported as:
Number · participants
Clinical Response at Follow-up Visit on Per Protocol Population
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Continued clinical cure157158
Continued failure, clinical recurrence/relapse2722
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -2.5 · 95% CI -8.6 to 4.9Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryClinical Response at Follow-up Visit on Intent To Treat Population

All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.

Time frame:
28 - 42 days after completion of study drug therapy
Reported as:
Number · participants
Clinical Response at Follow-up Visit on Intent To Treat Population
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Continued clinical cure166170
Failure, relapse, indeterminate, missing5960
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -0.1 · 95% CI -8.1 to 7.5Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryBacteriological Response at Follow-up Visit Microbiologically Valid

Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.

Time frame:
28 - 42 days after completion of study drug therapy
Reported as:
Number · participants
Bacteriological Response at Follow-up Visit Microbiologically Valid
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Eradication2322
Eradication with recurrence, persistence54
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): -7.9 · 95% CI -24.9 to 15.9Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryBacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism

Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.

Time frame:
28 - 42 days after completion of study drug therapy
Reported as:
Number · participants
Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Eradication2323
Eradication with recurrence, persistence1311
Statistical analysis
  • Moxifloxacin vs Levofloxacin Plus Metronidazole · Mean difference (final values): 3.7 · 95% CI -30.5 to 11.9Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
SecondaryNumber of Subjects Who Received Alternative Medicine

As alternative medicine any systemic antibacterial medication was considered.

Time frame:
Up to 42 days after end of treatment
Reported as:
Number · participants
Number of Subjects Who Received Alternative Medicine
participantsMoxifloxacinLevofloxacin Plus Metronidazole
Receiving alternative medicine41
Not receiving alternative medicine190189

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Moxifloxacin—3/225 (1.3%)83/225 (36.9%)
Levofloxacin Plus Metronidazole—1/230 (0.4%)94/230 (40.9%)
Most frequent serious events
Most frequent serious events
EventMoxifloxacinLevofloxacin Plus Metronidazole
ColitisGastrointestinal disorders1/2250/230
Abortion spontaneousPregnancy, puerperium and perinatal conditions1/2250/230
Stevens-Johnson syndromeSkin and subcutaneous tissue disorders1/2250/230
Pyelonephrits acuteInfections and infestations0/2251/230
Most frequent other events
Most frequent other events
EventMoxifloxacinLevofloxacin Plus Metronidazole
NauseaGastrointestinal disorders43/22554/230
DizzinessNervous system disorders39/22536/230
VomitingGastrointestinal disorders7/22515/230
Abdominal pain upperGastrointestinal disorders10/22514/230
InsomniaPsychiatric disorders7/22514/230

Baseline characteristics

Age, Continuous
Age, Continuous(years)MoxifloxacinLevofloxacin Plus MetronidazoleTotal
Mean35.2 ± 8.435.4 ± 8.735.2 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)MoxifloxacinLevofloxacin Plus MetronidazoleTotal
Female228232460
Male000
Microbiology recovery
Microbiology recovery(number of participants with pathogenes)MoxifloxacinLevofloxacin Plus MetronidazoleTotal
Number363672
Total pelvic pain score (using modified McCormack score)
Total pelvic pain score (using modified McCormack score)(points on a scale)MoxifloxacinLevofloxacin Plus MetronidazoleTotal
Mean11.3 ± 3.811.6 ± 3.811.5 ± 3.8
08

Study locations

13 sites
  • Shenyang, Liaoning 110004, China
  • Chengdu, Sichuan 610041, China
  • Beijing, 100034, China
  • Beijing, 100083, China
  • Chongqing, 400010, China
  • Shanghai, 200011, China
  • Jakarta, Indonesia
  • Seoul, 133792, Korea, Republic of
  • Karachi, Pakistan
  • Manila, Philippines
  • Taipei, 10002, Taiwan
  • Taizung, 402, Taiwan
  • Bangkok, 10700, Thailand
09

References and documents

Publications

  • Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18. PubMed 20716255 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00453349
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 28, 2007
Start date
Jan 2007
Primary completion
May 2008
Completion
May 2008
Results posted
Nov 30, 2009
Last update
Sep 8, 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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