search
Back to results

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

Primary Purpose

Vaginitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
POLYGYNAX®
GYNODAKTARIN®
Placebo
Sponsored by
Laboratoire Innotech International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginitis

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • TURKOVA
  • PERCEVAL
  • MARICIC
  • GATOVA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

POLYGYNAX®

miconazole + placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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)
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.
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.

Full Information

First Posted
July 29, 2015
Last Updated
August 13, 2018
Sponsor
Laboratoire Innotech International
Collaborators
International Clinical Trials Association, Venn Life Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02515656
Brief Title
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Acronym
PRISM
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire Innotech International
Collaborators
International Clinical Trials Association, Venn Life Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POLYGYNAX®
Arm Type
Experimental
Arm Description
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
Arm Title
miconazole + placebo
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
POLYGYNAX®
Intervention Type
Drug
Intervention Name(s)
GYNODAKTARIN®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit
Description
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.
Time Frame
15 days after first treatment administration
Secondary Outcome Measure Information:
Title
Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary
Description
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
Time Frame
during 14 days after first treatment intake
Title
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator
Description
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.
Time Frame
15 days after first treatment administration
Title
Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit
Description
Success and Failure (same definition as the primary outcome measure)
Time Frame
22 days after first treatment administration
Title
Investigator's Global Satisfaction
Description
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.
Time Frame
15 days after first administration
Title
Patient's Global Satisfaction
Description
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.
Time Frame
15 days after first administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc BOHBOT, Dr
Organizational Affiliation
Institut Alfred Fournier
Official's Role
Principal Investigator
Facility Information:
Facility Name
TURKOVA
City
Praha
Country
Czechia
Facility Name
PERCEVAL
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
MARICIC
City
Belgrade
Country
Serbia
Facility Name
GATOVA
City
Martin
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs