Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Launched by LABORATOIRE INNOTECH INTERNATIONAL · Aug 1, 2015
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
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:
- • 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
About Laboratoire Innotech International
Laboratoire Innotech International is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong focus on high-quality clinical studies, the organization specializes in a wide range of therapeutic areas, leveraging cutting-edge methodologies and a robust regulatory framework to ensure the safety and efficacy of new treatments. Committed to collaboration and ethical practices, Laboratoire Innotech International partners with healthcare professionals, research institutions, and regulatory bodies to facilitate the successful progression of novel therapies from concept to market, ultimately enhancing patient outcomes and driving advancements in medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Praha, , Czechia
Lyon, , France
Belgrade, , Serbia
Martin, , Slovakia
Patients applied
Trial Officials
Jean-Marc BOHBOT, Dr
Principal Investigator
Institut Alfred Fournier
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials