E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Patients presenting with abnormal vaginal discharge associated with vaginal burning and/or vaginal irritation and/or vaginal pain and diagnosed with vaginal infection needing a local treatment. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046950 |
E.1.2 | Term | Vaginitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046914 |
E.1.2 | Term | Vaginal infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029562 |
E.1.2 | Term | Non-specific vaginitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001107 |
E.1.2 | Term | Acute vaginitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062167 |
E.1.2 | Term | Vaginitis bacterial |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
10.10. Allergy or hypersensitivity to one of the components of POLYGYNAX® or to one of the components of comparator treatment (miconazole+placebo), this includes patients with allergy to peanut or soya for which the use of POLYGYNAX® is contraindicated
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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Visit 2 on D15 ± 1 day
If menstrual period at Visit 2, the visit is scheduled the day after the end of menses. |
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E.5.2 | 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 and if no alternative or specific treatment was begun before the Visit
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• For change in vaginal discharge and in each associated vaginal clinical symptoms (vaginal burning and/or vaginal pain and/or vaginal irritation) by the patient: Daily patient evaluation between Day 1 and Day 14 in the patient's diary
• For change in vaginal discharge compared to Baseline Visit by the investigator: Day 15 (± 1 day)
• For assessment of clinical treament efficacy by the investigator : At Visit 3 on D22 +/- 1 day
• For AE: Day 15 (± 1 day), Day 22 (± 1 day)
• For compliance: Day 15 (± 1 day)
• For investigator's global satisfaction: Day 15 (± 1 day)
• For patient's global satisfaction: Day 14 (in the patient diary)
• For microbiological status: Day 1
• For change of microbiological status: Day 22 (± 1 day) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 115 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Czech Republic |
France |
Serbia |
Slovakia |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 22 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 14 |
E.8.9.2 | In all countries concerned by the trial days | 22 |