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

Vaginitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515656
• Other study ID #: PGX 401-11
• Secondary ID: 2014-001759-22
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2018
• Source: Laboratoire Innotech International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginitis

Intervention

Drug:
• POLYGYNAX®

• GYNODAKTARIN®

• Placebo

Locations

Country	Name	City	State
Czechia	TURKOVA	Praha
France	PERCEVAL	Lyon
Serbia	MARICIC	Belgrade
Slovakia	GATOVA	Martin

Sponsors (3)

Lead Sponsor	Collaborator
Laboratoire Innotech International	International Clinical Trials Association, Venn Life Sciences

Countries where clinical trial is conducted

Czechia,  France,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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