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

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• Vaginitis 115

Vaginitis

115 studies on the registry are indexed under Vaginitis; 16 are open to participants now.

This study's enrollment of 661 is above the median of 100 across 90 interventional studies indexed under Vaginitis.

Lead sponsor

Laboratoire Innotech International is the lead sponsor of 5 studies on the registry; none are open to participants now.

Study arms

• Experimental
  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

  Drug: POLYGYNAX®

• Active comparator
  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

  Drug: GYNODAKTARIN® · Drug: Placebo

Interventions

• DrugPOLYGYNAX®
• DrugGYNODAKTARIN®
• DrugPlacebo

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

Baseline characteristics