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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

Tracking Information
First Submitted Date  ICMJE July 29, 2015
First Posted Date  ICMJE August 5, 2015
Results First Submitted Date  ICMJE September 21, 2017
Results First Posted Date  ICMJE January 21, 2019
Last Update Posted Date January 21, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2015)
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 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.
Change History Complete list of historical versions of study NCT02515656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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
  • 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.
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2015)
  • Change in vaginal discharge and in each associated vaginal clinical symptoms by the patient ( VAS) [ Time Frame: during 14 days after first treatment intake ]
    With VAS
  • Change in vaginal discharge compared before and after treatment assessed by the investigator (leucorrhoea score) [ Time Frame: 15 days ]
  • 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)
  • Number of adverse events [ Time Frame: 22 days (until last visit) ]
  • Percentage of adverse events [ Time Frame: 22 days (until last visit) ]
  • Number of capsules of treatment administrated [ Time Frame: 15 days ]
  • Investigator's Global Satisfaction [ Time Frame: 15 days after first administration ]
  • Patient's Global Satisfaction [ Time Frame: 15 days after first administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Official Title  ICMJE Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vaginitis
Intervention  ICMJE
  • Drug: POLYGYNAX®
  • Drug: GYNODAKTARIN®
  • Drug: Placebo
Study Arms  ICMJE
  • 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
    Intervention: 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
    Interventions:
    • Drug: GYNODAKTARIN®
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2018)
661
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2015)
650
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia,   Czechia,   France,   Serbia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02515656
Other Study ID Numbers  ICMJE PGX 401-11
2014-001759-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoire Innotech International
Study Sponsor  ICMJE Laboratoire Innotech International
Collaborators  ICMJE
  • International Clinical Trials Association
  • Venn Life Sciences
Investigators  ICMJE
Principal Investigator: Jean-Marc BOHBOT, Dr Institut Alfred Fournier
PRS Account Laboratoire Innotech International
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP