Overview

This trial has been completed.

Condition vaginitis
Treatments polygynax®, gynodaktarin®, placebo
Phase phase 3
Sponsor Laboratoire Innotech International
Collaborator International Clinical Trials Association
Start date September 2015
End date August 2016
Trial size 659 participants
Trial identifier NCT02515656, 2014-001759-22, PGX 401-11

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 combinaison 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
polygynax®
(Active Comparator)
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
gynodaktarin®
placebo

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Change in vaginal discharge and in each associated vaginal clinical symptoms by the patient ( VAS)
time frame: during 14 days after first treatment intake
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
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

Eligibility Criteria

Female participants from 18 years up to 64 years old.

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 plannus, 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 menometrorraghia due to hormonal imbalance at the time of inclusion 9. Pregnant or lactating women or delivery within last 1 month

Additional Information

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
Principal investigator Jean-Marc BOHBOT, Dr
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Laboratoire Innotech International.