Study to test the efficacy of POLYGYNAX® in patientspresenting with vaginal infections. POLYGYNAX® is compared tomiconazole followed by a placebo. Miconazole is another active treatment for vaginal infections.

Phase 1

Conditions: 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: 18.0Level: LLTClassification code 10046950Term: VaginitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0Level: PTClassification code 10046914Term: Vaginal infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0Level: LLTClassification code 10001107Term: Acute vaginitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0Level: LLTClassification code 10029562Term: Non-specific vaginitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0Level: PTClassification code 10062167Term: Vaginitis bacterialSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2014-001759-22-FR

Lead Sponsor: aboratoire Innotech International

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 658

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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