Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis (PRISM)
Vaginitis
About this trial
This is an interventional treatment trial for Vaginitis
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
Sites / Locations
- TURKOVA
- PERCEVAL
- MARICIC
- GATOVA
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
POLYGYNAX®
miconazole + placebo
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