Completed

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

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What is being tested

Moxifloxacin

+ Ofloxacin

+ Metronidazole

Drug
Who is being recruted

Urogenital Diseases+6

+ Genital Diseases

+ Adnexal Diseases

From 14 to 45 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: June 2010
See protocol details

Summary

Principal SponsorIstanbul Bakirkoy Maternity and Children Diseases Hospital
Last updated: August 28, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2010

Actual date on which the first participant was enrolled.

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

NCT01799356
Principal SponsorIstanbul Bakirkoy Maternity and Children Diseases Hospital
Last updated: August 28, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1303 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 14 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsPelvic InfectionFemale Urogenital DiseasesPelvic Inflammatory Disease

Criteria

3 inclusion criteria required to participate
Patients age are between 14 with 45
Pelvic tenderness and vaginal discharge
Women diagnosed uncomplicated PID
6 exclusion criteria prevent from participating
Delivery,abortion and surgery within last months
Endometriosis
Hıstory of antibiotics treatment
Other pelvic pain causes
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Treatment at uPID with moxifloxacin

Group II

Placebo
Treatment at uPID with Ofloxacin plus metronidazole

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

T.C.S.B. İstanbul Training Research Hospital

Samatya, Turkey (Türkiye)Open T.C.S.B. İstanbul Training Research Hospital in Google Maps

T.C.S.B. Kanuni Sultan Suleyman Training Hospital

Istanbul, Turkey (Türkiye)

T.C.S.B Mardin Women and Children Hospital

Mardin, Turkey (Türkiye)

T.C.S.B. Şişli Etfal Training Research Hospital

Şişli, Turkey (Türkiye)
Completed4 Study Centers