Vaginitis
Conditions
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.
Interventions
DRUGPOLYGYNAX®
DRUGGYNODAKTARIN®
DRUGPlacebo
Sponsors
International Clinical Trials Association
Venn Life Sciences
Laboratoire Innotech International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit | 15 days after first treatment administration | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | 15 days after first treatment administration | The vaginal discharge is assessed by the investigator by using a score: 0=absent 1. mild: insufficient for speculum collection 2. moderate: sufficient for speculum collection 3. abundant: visible at the introitus even before speculum introduction. |
| 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 | Success and Failure (same definition as the primary outcome measure) |
| Investigator's Global Satisfaction | 15 days after first administration | 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. |
| Patient's Global Satisfaction | 15 days after first administration | 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. |
Countries
Czechia, France, Serbia, Slovakia
Participant flow
Pre-assignment details
3 patients who signed an Informed Consent Form (ICF) were screen failed and were not randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| POLYGYNAX® 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
POLYGYNAX® | 302 |
| Miconazole + Placebo 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
GYNODAKTARIN®
Placebo | 309 |
| Total | 611 |
Baseline characteristics
| Characteristic | POLYGYNAX® | Miconazole + Placebo | Total |
|---|---|---|---|
| Age, Continuous | 34.70 years STANDARD_DEVIATION 10.13 | 33.73 years STANDARD_DEVIATION 10.07 | 34.21 years STANDARD_DEVIATION 10.11 |
| Sex: Female, Male Female | 302 Participants | 309 Participants | 611 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 325 | 0 / 328 |
| other Total, other adverse events | 18 / 325 | 5 / 328 |
| serious Total, serious adverse events | 1 / 325 | 0 / 328 |
Outcome results
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.
Time frame: 15 days after first treatment administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| POLYGYNAX® | Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit | Success | 275 Participants |
| POLYGYNAX® | Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit | Failure | 27 Participants |
| Miconazole + Placebo | Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit | Success | 268 Participants |
| Miconazole + Placebo | Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit | Failure | 41 Participants |
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
Time frame: during 14 days after first treatment intake
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| POLYGYNAX® | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal combined clinical symptoms score absolute | 28.96 mm |
| POLYGYNAX® | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal irritation absolute change | 29.37 mm |
| POLYGYNAX® | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal discharge absolute change | 31.43 mm |
| POLYGYNAX® | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal pain absolute change | 16.93 mm |
| POLYGYNAX® | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal burning absolute change | 27.89 mm |
| Miconazole + Placebo | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal pain absolute change | 17.17 mm |
| Miconazole + Placebo | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal burning absolute change | 27.03 mm |
| Miconazole + Placebo | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal irritation absolute change | 28.79 mm |
| Miconazole + Placebo | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal combined clinical symptoms score absolute | 28.20 mm |
| Miconazole + Placebo | Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary | Vaginal discharge absolute change | 29.54 mm |
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)
Time frame: 22 days after first treatment administration
Population: There were 5 and 6 missing values respectively in Polygynax and Miconazole + placebo arms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| POLYGYNAX® | Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit | Success | 252 Participants |
| POLYGYNAX® | Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit | Failure | 45 Participants |
| Miconazole + Placebo | Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit | Success | 250 Participants |
| Miconazole + Placebo | Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit | Failure | 53 Participants |
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.
Time frame: 15 days after first administration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| POLYGYNAX® | Investigator's Global Satisfaction | Bad - Very bad | 10 Participants |
| POLYGYNAX® | Investigator's Global Satisfaction | Very good - Good | 265 Participants |
| POLYGYNAX® | Investigator's Global Satisfaction | Somewhat good - Somewhat bad | 25 Participants |
| Miconazole + Placebo | Investigator's Global Satisfaction | Bad - Very bad | 15 Participants |
| Miconazole + Placebo | Investigator's Global Satisfaction | Very good - Good | 252 Participants |
| Miconazole + Placebo | Investigator's Global Satisfaction | Somewhat good - Somewhat bad | 40 Participants |
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 1. mild: insufficient for speculum collection 2. moderate: sufficient for speculum collection 3. abundant: visible at the introitus even before speculum introduction.
Time frame: 15 days after first treatment administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| POLYGYNAX® | Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | Leucorrhoea score change - Deterioration | 1 Participants |
| POLYGYNAX® | Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | Leucorrhoea score change - No change | 19 Participants |
| POLYGYNAX® | Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | Leucorrhoea score change - Improvement | 280 Participants |
| Miconazole + Placebo | Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | Leucorrhoea score change - Deterioration | 7 Participants |
| Miconazole + Placebo | Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | Leucorrhoea score change - No change | 24 Participants |
| Miconazole + Placebo | Number of Patients With Change in Vaginal Discharge Assessed by the Investigator | Leucorrhoea score change - Improvement | 276 Participants |
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.
Time frame: 15 days after first administration
Population: There were 10 and 11 missing values respectively in Polygynax and Miconazole + placebo arms.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| POLYGYNAX® | Patient's Global Satisfaction | Very good - Good | 239 Participants |
| POLYGYNAX® | Patient's Global Satisfaction | Somewhat good - Somewhat bad | 50 Participants |
| POLYGYNAX® | Patient's Global Satisfaction | Bad - Very bad | 3 Participants |
| Miconazole + Placebo | Patient's Global Satisfaction | Very good - Good | 233 Participants |
| Miconazole + Placebo | Patient's Global Satisfaction | Somewhat good - Somewhat bad | 63 Participants |
| Miconazole + Placebo | Patient's Global Satisfaction | Bad - Very bad | 2 Participants |