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NCT Number: NCT02515656

Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

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.

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Key information

Conditions

Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

TURKOVA, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
  • Vaginal infection justifying systemic therapy
  • History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
  • 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))
  • Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
  • Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
  • Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
  • Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion
  • Pregnant or lactating women or delivery within last 1 month

Treatment and study plan

POLYGYNAX®

Drug

GYNODAKTARIN®

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

    • mild: insufficient for speculum collection
    • moderate: sufficient for speculum collection
    • 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.

Sponsors and collaborators

Lead sponsor

Laboratoire Innotech International

Industry

Collaborators

  • International Clinical Trials Association
  • Venn Life Sciences

Registry information

Official study 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

Acronym: PRISM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2015
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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