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CompletedNCT01799356Updated Aug 28, 2013

Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials

A Phase 4 interventional study of Moxifloxacin and Ofloxacin in Pelvic Inflammatory Disease, sponsored by Istanbul Bakirkoy Maternity and Children Diseases Hospital. Completed at 4 sites in Turkey. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-28.

Sponsored by Istanbul Bakirkoy Maternity and Children Diseases Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,303
Allocation
Randomized
Ages
14 Years to 45 Years
Sex
Female
01

Study summary

We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days

02

Conditions studied

  • Pelvic Inflammatory Disease

Keywords

  • Treatment, moksifloksasin
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 1,303 is above the median of 163 across 30 interventional studies indexed under Pelvic Inflammatory Disease.

Browse Pelvic Inflammatory Disease studies →

Lead sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Women diagnosed uncomplicated PID
  2. Patients age are between 14 with 45
  3. Pelvic tenderness and vaginal discharge

Exclusion criteria

Exclusion Criteria:

  1. Urinary Tract Enfections
  2. Tubo-ovarian abscess and complicated PID
  3. Hıstory of antibiotics treatment
  4. Other pelvic pain causes
  5. Endometriosis
  6. Delivery,abortion and surgery within last months
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
1,303 participants (actual)

Study arms

  • Active comparator
    moxifloxacin Group

    Treatment at uPID with moxifloxacin

    Drug: Moxifloxacin

  • Placebo comparator
    Ofloxacin Group

    Treatment at uPID with Ofloxacin plus metronidazole

    Drug: Ofloxacin · Drug: Metronidazole

Interventions

  • DrugMoxifloxacin

    daily 400 mg moksifloksasin

    Also known as: new generetaion flouroquinolon antibiotics

  • DrugOfloxacin

    daily 800 mg oflaksasin plus 1000 mg metronidazol treatment

    Also known as: floroquinolon antibiotics

  • DrugMetronidazole

    daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID

    Also known as: anaerobic antibiotics

06

What researchers measure

Primary outcomes

  1. Clinically cure

    Time frame: 21 Days

Secondary outcomes

  1. Microbiological cure

    Time frame: 21 Days

07

Study locations

4 sites
  • T.C.S.B. İstanbul Training Research Hospital
    Samatya, Fatih 34180, Turkey
  • T.C.S.B. Kanuni Sultan Suleyman Training Hospital
    İstanbul, Kucukcekmece 34280, Turkey
  • T.C.S.B Mardin Women and Children Hospital
    Mardin, 47000, Turkey
  • T.C.S.B. Şişli Etfal Training Research Hospital
    Şişli, 34150, Turkey
08

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 ↗
  • Boothby M, Page J, Pryor R, Ross JD. A comparison of treatment outcomes for moxifloxacin versus ofloxacin/metronidazole for first-line treatment of uncomplicated non-gonococcal pelvic inflammatory disease. Int J STD AIDS. 2010 Mar;21(3):195-7. doi: 10.1258/ijsa.2009.009374. PubMed 20215625 ↗
  • Savaris RF, Fuhrich DG, Maissiat J, Duarte RV, Ross J. Antibiotic therapy for pelvic inflammatory disease. Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD010285. doi: 10.1002/14651858.CD010285.pub3. PubMed 32820536 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01799356
Lead sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Responsible party
Osman Aşıcıoğlu (Istanbul Sisli Etfal Training Research Hospital, Istanbul Bakirkoy Maternity and Children Diseases Hospital) — Principal investigator
First posted
Feb 26, 2013
Start date
Jun 2010
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Aug 28, 2013

Study contacts

Kemal Gungorduk, md
study chair · T.C.S.B. Kanıni Sultan Suleyman Training Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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