Clinical trial NCT02515656: Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginitis
Lead sponsor: Laboratoire Innotech International
Sponsor class: INDUSTRY
Collaborators: name: International Clinical Trials Association
name: Venn Life Sciences
First posted: 2015-08-05
Enrollment: 661
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit
timeFrame: 15 days after first treatment administration
Secondary outcomes:
measure: Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary
timeFrame: during 14 days after first treatment intake
measure: Number of Patients With Change in Vaginal Discharge Assessed by the Investigator
timeFrame: 15 days after first treatment administration
measure: Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit
timeFrame: 22 days after first treatment administration
measure: Investigator's Global Satisfaction
timeFrame: 15 days after first administration
measure: Patient's Global Satisfaction
timeFrame: 15 days after first administration
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: TURKOVA
city: Lyon
country: France
facility: PERCEVAL
city: Belgrade
country: Serbia
facility: MARICIC
city: Martin
country: Slovakia
facility: GATOVA
Study officials:
affiliation: Institut Alfred Fournier
name: Jean-Marc BOHBOT, Dr
role: PRINCIPAL_INVESTIGATOR
References: