Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Information source: Laboratoire Innotech International
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginitis
Intervention: POLYGYNAX® (Drug); GYNODAKTARIN® (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Laboratoire Innotech International Overall contact: Laboratoire Innotech International PRISM, Email: prism@innothera.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Clinical treatment efficacy assessed by the investigator after thorough gynaecological examination and patient's interview at End of Treatment Visit
Secondary outcome: Change in vaginal discharge and in each associated vaginal clinical symptoms by the patient ( VAS)Change in vaginal discharge compared before and after treatment assessed by the investigator (leucorrhoea score) Clinical treatment efficacy (success/failure) assessed by the investigator after thorough gynaecological examination and patient's interview at End of Study Visit Number of adverse events Percentage of adverse events Number of capsules of treatment administrated Investigator's global satisfaction Patient's global satisfaction
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Female.
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 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
Locations and Contacts
Laboratoire Innotech International PRISM, Email: prism@innothera.com Additional Information
Starting date: August 2015
Last updated: August 1, 2015
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