Phase 3
N=658
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Vaginitis
Bottom Line
View on ClinicalTrials.gov: NCT02515656 ↗Enrolled (actual)
658
Serious AEs
0.2%
Results posted
Jan 2019
Primary outcome: Primary: Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit — 275; 268; 27; 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- POLYGYNAX® (Drug); GYNODAKTARIN® (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Laboratoire Innotech International
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit |
275; 268; 27; 41 | — |
| SECONDARY Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary |
31.43; 29.54; 27.89; 27.03; 16.93; 17.17 | — |
| SECONDARY Number of Patients With Change in Vaginal Discharge Assessed by the Investigator |
1; 7; 19; 24; 280; 276 | — |
| SECONDARY Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit |
252; 250; 45; 53 | — |
| SECONDARY Investigator's Global Satisfaction |
265; 252; 25; 40; 10; 15 | — |
| SECONDARY Patient's Global Satisfaction |
239; 233; 50; 63; 3; 2 | — |
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.
Eligibility 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
- Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
- Vaginal infection justifying systemic therapy
- History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
- 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)
- Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
- Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion
- Pregnant or lactating women or delivery within last 1 month
Data sourced from ClinicalTrials.gov (NCT02515656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.