To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment

NCT ID: NCT01241110

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin +Metronidazole in outpatients with Pelvic Inflammatory Disease.

Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy

Detailed Description

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Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy

Conditions

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Pelvic Inflammatory Disease

Keywords

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PID, Ofloxacin, Azitromicine, Metronidazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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azitromicin,PID treatment,ofluxacin

Group Type ACTIVE_COMPARATOR

Ofloxacin group A, Azitromycin group B

Intervention Type DRUG

Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy.

azitromycin

Intervention Type DRUG

azitromicin vs ofluxacin

Interventions

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Ofloxacin group A, Azitromycin group B

Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy.

Intervention Type DRUG

azitromycin

azitromicin vs ofluxacin

Intervention Type DRUG

Other Intervention Names

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azitromicin, ofluxacin azitromicin ofluxacin

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guilan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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GUMS

Principal Investigators

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Fariba Mirblook, MD

Role: PRINCIPAL_INVESTIGATOR

Guilan University of Medical Sciences

Locations

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Alzahra Maternity Hospital

Rasht, Gilan Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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R01DA013131

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ClinicalTrials.gov

Identifier Type: -

Identifier Source: org_study_id