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

Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole

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.

Study Overview

• Status: Completed
• Conditions: Vaginitis
• Intervention / Treatment: Drug: Placebo; Drug: POLYGYNAX®; Drug: GYNODAKTARIN®

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia
    • TURKOVA
• France
  • Lyon, France, 69009
    • PERCEVAL
• Serbia
  • Belgrade, Serbia
    • MARICIC
• Slovakia
  • Martin, Slovakia
    • GATOVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Placebo; Drug: GYNODAKTARIN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary	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	during 14 days after first treatment intake
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator	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.	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	Success and Failure (same definition as the primary outcome measure)	22 days after first treatment administration
Investigator's Global Satisfaction	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.	15 days after first administration
Patient's Global Satisfaction	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.	15 days after first administration

Collaborators and Investigators

• Sponsor: Laboratoire Innotech International
• Collaborators: International Clinical Trials Association; Venn Life Sciences
• Investigators: Principal Investigator: Jean-Marc BOHBOT, Dr, Institut Alfred Fournier

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: August 1, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginitis
• Other Study ID Numbers: PGX 401-11; 2014-001759-22 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No