Patients presenting with abnormal vaginal discharge associated with other vaginal symptoms (i.e. vaginal burning and/or vaginal irritation and/or vaginal pain) clinically evoking infectious vaginitis (bacterial vaginitis, non specific vaginitis or mixed vaginitis) after thorough gynecological examination and for whom an empirical local treatment is warranted. MedDRA version: 18.0 Level: LLT Classification code 10046950 Term: Vaginitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: POLYGYNAX®
Pharmaceutical Form: Vaginal capsule, soft
Trade Name: GYNODAKTARIN®
Pharmaceutical Form: Vaginal capsule, soft
Pharmaceutical form of the placebo: Vaginal capsule, soft
Route
Sponsors
Laboratoire Innotech International
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female outpatients, aged 18 to 64, who have read, understood, signed and dated the informed consent form 2. 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 3. Patient for whom follow-up by the investigator for 22 days is possible and able/accepts to comply with the study constraints 4. Patient affiliated to a public health insurance coverage Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 650 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 (recent history of STI (within 2 months prior to inclusion), infected partner, suggestive symptoms, etc.) 6. Patient with underlying debilitating medical conditions 7. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments) 8. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion 9. Patient with surgery scheduled during the study 10. Allergy or hypersensitivity to one of the components of POLYGYNAX® or to one of the components of comparator treatment (miconazole+placebo) 11. Patient menstruating or patient with menometrorraghia due to hormonal imbalance at the time of inclusion 12. Patient lactating, or who has delivered within four weeks prior to inclusion 13. For patients of childbearing age, patient with a positive urine pregnancy test on the day of the Baseline Visit (Visit 1 / D1) 14. Use of spermicide products (associated or not with a diaphragm) within two weeks prior to inclusion 15. Patient having used an intra vaginal hormonal treatment (including intra vaginal ring) within four weeks prior to inclusion 16. For patients of childbearing age, patient not using effective contraception method or using an effective method which needs to be changed or stopped during the study (NB : Use of a latex diaphragm, and/or latex condoms and/or a spermicide is not allowed during the study) 17. Patient participating or having participated in a clinical trial within four weeks prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superior clinical efficacy of POLYGYNAX® at the End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) compared to miconazole in the empirical treatment of infectious vaginitis;Secondary Objective: • Comparison of the changes in symptoms (from Visit 1 / D1 to Visit 2 / D15 or Premature Discontinuation Visit if any) between the 2 treatments • Assessment of the clinical efficacy of the 2 treatments at End of Study Visit (Visit 3 / D22 or Premature Discontinuation Visit if any) • Assessment of the safety of the 2 treatments • Assessment of the compliance with the 2 treatments • Assessment of patients’ and investigators’ global satisfaction with the 2 treatments • Description of the microbiological status at Baseline Visit (Visit 1 / D1) and assessment of the proportion of fungal, bacterial and mixed vaginitis, bacterial vaginosis and imbalance of vaginal flora • Description of the microbiological changes during follow-up (between Baseline Visit (Visit 1 / D1) and End of Study Visit (Visit 3 / D22 or Premature Discontinuation Visit if any) if a clinical treatment failure is assessed by the investigator and if no alternative or specific treatment is begun before these visits;Primary end point(s): Clinical treatment efficacy assessed by the investigator after thorough gynaecological examination and patient’s interview at End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any). • Success is defined by resolution (return to patient’s usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation). • Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in vaginal discharge and in each associated vaginal clinical symptoms (vaginal burning and/or vaginal pain and/or vaginal irritation) compared to Baseline Visit (Visit 1 / D1), by means of daily self-assessment on Visual Analogue Scale (VAS) by the patient from D1 to D14 • Change in vaginal discharge compared to Baseline Visit (Visit 1 / D1), as assessed by the investigator at End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) by a leucorrhoea score (0 = absent; 1 = mild: insufficient for speculum collection; 2 = moderate: sufficient for speculum collection; 3 = abundant: visible at the introitus even before speculum introduction). If patients have their menstrual period at Visit 2, the clinical assessment is scheduled the day after the end of menses • Clinical treatment efficacy (success/failure) assessed by the investigator after thorough gynaecological examination and patient’s interview at End of Study Visit (Visit 3 / D22 or Premature Discontinuation Visit if any) • Number and percentage of adverse events during the study and causal role of study treatments • Compliance with treatments (number of vaginal capsules administered between Baseline Visit (Visit 1 / D1) and End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) • Investigator’s global satisfaction assessed at End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) • Patients’ global satisfaction assessed on the eve of End of Treatment Visit (Visit 2 / D15 or Premature Discontinuation Visit if any) • Microbiological status of patients at Baseline Visit (Visit 1 / D1) and proportion of fungal, bacterial and mixed vaginitis, bacterial vaginosis and imbalance of vaginal flora • Change in microbiological status between Baseline Visit (Visit 1 / D1) and End of Study Visit (Visit 3 / D22) or Premature Discontinuation Visit if a clinical treatment failure is assessed by the investigator a | — |
Countries
Czech Republic, France, Slovakia
Contacts
Public ContactMedical Affairs Department
Laboratoire Innotech International
Outcome results
None listed