Overview

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

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratoire Innotech International
Collaborators:
International Clinical Trials Association
Venn Life Sciences
Treatments:
Miconazole
Neomycin
Nystatin
Polymyxins
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:

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