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Search / Trial NCT02515656

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.

Locations

Praha, , Czechia

Lyon, , France

Belgrade, , Serbia

Martin, , Slovakia

Patients applied

0 patients applied

Trial Officials

Jean-Marc BOHBOT, Dr

Principal Investigator

Institut Alfred Fournier

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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