Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02515656
Other study ID # PGX 401-11
Secondary ID 2014-001759-22
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2015
Est. completion date August 2016

Study information

Verified date August 2018
Source Laboratoire Innotech International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 661
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
POLYGYNAX®

GYNODAKTARIN®

Placebo


Locations

Country Name City State
Czechia TURKOVA Praha
France PERCEVAL Lyon
Serbia MARICIC Belgrade
Slovakia GATOVA Martin

Sponsors (3)

Lead Sponsor Collaborator
Laboratoire Innotech International International Clinical Trials Association, Venn Life Sciences

Countries where clinical trial is conducted

Czechia,  France,  Serbia,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary This outcome was evaluated using a Visual Analogue Scale (VAS) completed by the patient.
The scale measured the level of each vaginal symptom experienced during the day (vaginal discharge, vaginal burning, vaginal pain and vaginal irritation).
Scale ranges = 0 to 100 0=none symptom 100=maximum intensity of symptom Time points used in the calculation= D1 to D14
during 14 days after first treatment intake
Secondary Number of Patients With Change in Vaginal Discharge Assessed by the Investigator The vaginal discharge is assessed by the investigator by using a score:
0=absent
mild: insufficient for speculum collection
moderate: sufficient for speculum collection
abundant: visible at the introitus even before speculum introduction.
15 days after first treatment administration
Secondary Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit Success and Failure (same definition as the primary outcome measure) 22 days after first treatment administration
Secondary Investigator's Global Satisfaction The investigator filled the satisfaction questionnaire during the end of treatment visit.
Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.
15 days after first administration
Secondary Patient's Global Satisfaction The patient filled the satisfaction questionnaire on her patient's diary at home the eve of the End of Treatment Visit.
Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.
15 days after first administration
See also
  Status Clinical Trial Phase
Recruiting NCT01420510 - Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis Phase 2/Phase 3
Completed NCT04079218 - Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial Phase 4
Recruiting NCT05557318 - Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge N/A
Completed NCT01436513 - A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. Phase 1
Completed NCT03585049 - Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
Completed NCT04676503 - Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With History of Vaginitis/Vaginosis N/A
Completed NCT02641717 - Validity of Patient-Collected Wet Mounts N/A
Recruiting NCT05587283 - Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women Phase 1
Not yet recruiting NCT06070454 - Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions N/A
Completed NCT02365389 - Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis Phase 2/Phase 3
Completed NCT01050465 - MedlinePlus Health Prescriptions: Developing a Pragmatic Approach for Clinic Use N/A
Completed NCT05652959 - Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Recruiting NCT02763696 - Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota N/A
Recruiting NCT04574089 - Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository Phase 3
Recruiting NCT04816903 - Gyni™ Study With Leumit Health Services N/A
Completed NCT05670535 - Sjögren and Gynecologic Considerations
Not yet recruiting NCT06438575 - Point of Care Diagnosis of Vaginal Infections N/A
Enrolling by invitation NCT04984460 - Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals
Completed NCT03151928 - Diagnostic Accuracy By Providers Study
Completed NCT05396261 - a Flexible Wound Dressing for the Management of Genital Skin Conditions N/A