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Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis (PRISM)

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ClinicalTrials.gov Identifier: NCT02515656
Recruitment Status : Completed
First Posted : August 5, 2015
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
International Clinical Trials Association
Venn Life Sciences
Information provided by (Responsible Party):
Laboratoire Innotech International

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Vaginitis Drug: POLYGYNAX® Drug: GYNODAKTARIN® Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole
Study Start Date : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Experimental: POLYGYNAX®
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
Drug: POLYGYNAX®
Active Comparator: miconazole + placebo
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
Drug: GYNODAKTARIN®
Drug: Placebo



Primary Outcome Measures :
  1. Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit [ Time Frame: 15 days after first treatment administration ]
    • 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.


Secondary Outcome Measures :
  1. Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary [ Time Frame: during 14 days after first treatment intake ]

    This outcome was evaluated using a Visual Analogue Scale (VAS) completed by the patient.

    The scale measured the level of each vaginal symptom experienced during the day (vaginal discharge, vaginal burning, vaginal pain and vaginal irritation).

    Scale ranges = 0 to 100 0=none symptom 100=maximum intensity of symptom Time points used in the calculation= D1 to D14


  2. Number of Patients With Change in Vaginal Discharge Assessed by the Investigator [ Time Frame: 15 days after first treatment administration ]

    The vaginal discharge is assessed by the investigator by using a score:

    0=absent

    1. mild: insufficient for speculum collection
    2. moderate: sufficient for speculum collection
    3. abundant: visible at the introitus even before speculum introduction.

  3. Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit [ Time Frame: 22 days after first treatment administration ]
    Success and Failure (same definition as the primary outcome measure)

  4. Investigator's Global Satisfaction [ Time Frame: 15 days after first administration ]

    The investigator filled the satisfaction questionnaire during the end of treatment visit.

    Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.


  5. Patient's Global Satisfaction [ Time Frame: 15 days after first administration ]

    The patient filled the satisfaction questionnaire on her patient's diary at home the eve of the End of Treatment Visit.

    Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.




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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:

    • bacterial vaginitis
    • non-specific vaginitis (atypical symptoms)
    • mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an empirical local treatment

Exclusion Criteria:

  1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
  2. Vaginal infection justifying systemic therapy
  3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
  4. Patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
  5. Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
  6. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
  7. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
  8. Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion
  9. Pregnant or lactating women or delivery within last 1 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515656


Locations
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Czechia
TURKOVA
Praha, Czechia
France
PERCEVAL
Lyon, France, 69009
Serbia
MARICIC
Belgrade, Serbia
Slovakia
GATOVA
Martin, Slovakia
Sponsors and Collaborators
Laboratoire Innotech International
International Clinical Trials Association
Venn Life Sciences
Investigators
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Principal Investigator: Jean-Marc BOHBOT, Dr Institut Alfred Fournier

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Responsible Party: Laboratoire Innotech International
ClinicalTrials.gov Identifier: NCT02515656     History of Changes
Other Study ID Numbers: PGX 401-11
2014-001759-22 ( EudraCT Number )
First Posted: August 5, 2015    Key Record Dates
Results First Posted: January 21, 2019
Last Update Posted: January 21, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Vaginitis
Vaginal Diseases
Genital Diseases, Female
Miconazole
Nystatin
Neomycin
Polymyxins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Ionophores
Membrane Transport Modulators