Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

NCT02515656 | Completed Phase 3 Results DMC

• 2 other identifiers: PGX 401-112014-001759-22
• Study Type: interventional
• Target: 661
• Locations: 4 countries
• Sites: 4

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.

Conditions

Vaginitis

Outcome Measures

Primary Outcomes (1)

• Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit

  * 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. Not considered as "Treatment Failure": * The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1. * Patients presenting with only vulvar complaints not considered as related to infectious vaginitis.

  15 days after first treatment administration

Secondary Outcomes (5)

• Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary

  during 14 days after first treatment intake

• Number of Patients With Change in Vaginal Discharge Assessed by the Investigator

  15 days after first treatment administration

• Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit

  22 days after first treatment administration

• Investigator's Global Satisfaction

  15 days after first administration

• Patient's Global Satisfaction

  15 days after first administration

Study Arms (2)

POLYGYNAX®

EXPERIMENTAL

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

Drug: POLYGYNAX®

miconazole + placebo

ACTIVE COMPARATOR

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

Drug: GYNODAKTARIN®; Drug: Placebo

Interventions

POLYGYNAX® DRUG

POLYGYNAX®

GYNODAKTARIN® DRUG

miconazole + placebo

Placebo DRUG

miconazole + placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Vaginal infection justifying systemic therapy
• 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))
• Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
• Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
• Pregnant or lactating women or delivery within last 1 month

Sponsors & Collaborators

• Laboratoire Innotech International: lead
• International Clinical Trials Association: collaborator
• Venn Life Sciences: collaborator

Study Sites (4)

TURKOVA

Prague, Czechia

Location

PERCEVAL

Lyon, 69009, France

Location

MARICIC

Belgrade, Serbia

Location

GATOVA

Martin, Slovakia

Location

MeSH Terms

Conditions

Vaginitis

Interventions

acetarsol, dimethicone, neomycin, nystatin, polymyxin drug combination

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: Laboratoire Innotech International

+33 (0)1 46 15 29 00

Study Officials

• Jean-Marc BOHBOT, Dr

  Institut Alfred Fournier

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 5, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 22, 2019
• Results First Posted: January 22, 2019

Record last verified: 2018-08

Locations

SE (1); CZ (1); FR (1); SL (1)