NCT02515656|CompletedPhase 3ResultsDMC
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
PRISM
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
661
4 countries
4
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)Study Completion
August 2016
Actual (reported)POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969. Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone. The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2015
Actual (reported)August 5, 2015
Actual (reported)September 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 2016
Actual (reported)August 2016
Actual (reported)January 22, 2019
Actual (reported)Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit
* Success is defined by resolution (return to patient's usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation). * Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment. Not considered as "Treatment Failure": * The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1. * Patients presenting with only vulvar complaints not considered as related to infectious vaginitis.
15 days after first treatment administration
Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary
during 14 days after first treatment intake
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator
15 days after first treatment administration
Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit
22 days after first treatment administration
Investigator's Global Satisfaction
15 days after first administration
Patient's Global Satisfaction
15 days after first administration
Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules
Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules
TURKOVA
Prague, Czechia
PERCEVAL
Lyon, 69009, France
MARICIC
Belgrade, Serbia
GATOVA
Martin, Slovakia
Jean-Marc BOHBOT, Dr
Institut Alfred Fournier
661 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2015
First Posted
August 5, 2015
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
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Primary Completion
August 2016
Actual (reported)Study Completion
August 2016
Actual (reported)Last Updated
January 22, 2019
Results First Posted
January 22, 2019
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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