Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis (PRISM)

Laboratoire INNOTECH

Status and phase: Completed; Phase 3

Conditions: Vaginitis

Treatments: Drug: POLYGYNAX®; Drug: Placebo; Drug: GYNODAKTARIN®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02515656

2014-001759-22 (EudraCT Number)

PGX 401-11

Details and patient eligibility

About

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.

Enrollment: 661 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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661 participants in 2 patient groups

POLYGYNAX®

Experimental group

Description:

Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules

Treatment:

Drug: POLYGYNAX®

miconazole + placebo

Active Comparator group

Description:

Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules

Treatment:

Drug: Placebo

Drug: GYNODAKTARIN®