Pelvic Inflammatory Disease Clinical Trial
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
Status | Completed |
Enrollment | 1303 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Women diagnosed uncomplicated PID 2. Patients age are between 14 with 45 3. Pelvic tenderness and vaginal discharge Exclusion Criteria: 1. Urinary Tract Enfections 2. Tubo-ovarian abscess and complicated PID 3. History of antibiotics treatment 4. Other pelvic pain causes 5. Endometriosis 6. Delivery,abortion and surgery within last months |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | T.C.S.B. Kanuni Sultan Suleyman Training Hospital | Istanbul | Kucukcekmece |
Turkey | T.C.S.B Mardin Women and Children Hospital | Mardin | |
Turkey | T.C.S.B. Istanbul Training Research Hospital | Samatya | Fatih |
Turkey | T.C.S.B. Sisli Etfal Training Research Hospital | Sisli |
Lead Sponsor | Collaborator |
---|---|
Istanbul Bakirkoy Maternity and Children Diseases Hospital |
Turkey,
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: 10.125 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinically cure | 21 Days | Yes | |
Secondary | Microbiological cure | 21 Days | Yes |
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