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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001759-22 | EudraCT Number |
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| Name | Class |
|---|---|
| International Clinical Trials Association | OTHER |
| Venn Life Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POLYGYNAX® | Drug |
| ||
| GYNODAKTARIN® |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit |
Not considered as "Treatment Failure":
| 15 days after first treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc BOHBOT, Dr | Institut Alfred Fournier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TURKOVA | Prague | Czechia | ||||
| PERCEVAL |
3 patients who signed an Informed Consent Form (ICF) were screen failed and were not randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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® |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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® |
| BG001 | Miconazole + Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit |
Not considered as "Treatment Failure":
| Posted | Count of Participants | Participants | 15 days after first treatment administration |
|
22 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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® |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient pregnant exposed to study medications | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Laboratoire Innotech International | +33 (0)1 46 15 29 00 |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C006119 | acetarsol, dimethicone, neomycin, nystatin, polymyxin drug combination |
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|
| Placebo | Drug |
|
| during 14 days after first treatment intake |
| 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
| 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 | Success and Failure (same definition as the primary outcome measure) | 22 days after first treatment administration |
| 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 |
| 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 |
| Lyon |
| 69009 |
| France |
| MARICIC | Belgrade | Serbia |
| GATOVA | Martin | Slovakia |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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® |
| OG001 | 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 |
|
|
| 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 | Posted | Least Squares Mean | 95% Confidence Interval | mm | 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
| Posted | Count of Participants | Participants | 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) | There were 5 and 6 missing values respectively in Polygynax and Miconazole + placebo arms. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | There were 10 and 11 missing values respectively in Polygynax and Miconazole + placebo arms. | Posted | Count of Participants | Participants | 15 days after first administration |
|
|
|
| 0 |
| 325 |
| 1 |
| 325 |
| 18 |
| 325 |
| EG001 | 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 | 0 | 328 | 0 | 328 | 5 | 328 |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Vaginal pain absolute change |
|
| Vaginal irritation absolute change |
|
| Vaginal combined clinical symptoms score absolute |
|
| Leucorrhoea score change - Improvement |
|
| Failure |
|
|
| Bad - Very bad |
|
| Bad - Very bad |
|