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

Information source: Laboratoire Innotech International
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vaginitis

Intervention: POLYGYNAX® (Drug); GYNODAKTARIN® (Drug); Placebo (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Laboratoire Innotech International

Overall contact:
Laboratoire Innotech International PRISM, Email: prism@innothera.com

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 combinaison 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.

Clinical Details

Official title: Assessment of the Efficacy of POLYGYNAX in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical treatment efficacy assessed by the investigator after thorough gynaecological examination and patient's interview at End of Treatment Visit

Secondary outcome:

Change in vaginal discharge and in each associated vaginal clinical symptoms by the patient ( VAS)

Change in vaginal discharge compared before and after treatment assessed by the investigator (leucorrhoea score)

Clinical treatment efficacy (success/failure) assessed by the investigator after thorough gynaecological examination and patient's interview at End of Study Visit

Number of adverse events

Percentage of adverse events

Number of capsules of treatment administrated

Investigator's global satisfaction

Patient's global satisfaction

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Female.

Criteria:

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 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 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 menometrorraghia due to hormonal imbalance at the time of inclusion 9. Pregnant or lactating women or delivery within last 1 month

Locations and Contacts

Laboratoire Innotech International PRISM, Email: prism@innothera.com

Additional Information

Starting date: August 2015
Last updated: August 1, 2015

Page last updated: August 23, 2015

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