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Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis (PRISM)

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ClinicalTrials.gov Identifier: NCT02515656
Recruitment Status : Completed
First Posted : August 5, 2015
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
International Clinical Trials Association
Venn Life Sciences
Information provided by (Responsible Party):
Laboratoire Innotech International

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Vaginitis
Interventions Drug: POLYGYNAX®
Drug: GYNODAKTARIN®
Drug: Placebo
Enrollment 661
Recruitment Details  
Pre-assignment Details 3 patients who signed an Informed Consent Form (ICF) were screen failed and were not randomized in the study.
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description

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®

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

Period Title: Overall Study
Started 326 332
Full Analysis Set (FAS) 302 309
Per Protocol Set (PPS) 277 275
Safety Population 325 328
Completed 270 261
Not Completed 56 71
Arm/Group Title POLYGYNAX® Miconazole + Placebo Total
Hide Arm/Group Description

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®

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

Total of all reporting groups
Overall Number of Baseline Participants 302 309 611
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 302 participants 309 participants 611 participants
34.70  (10.13) 33.73  (10.07) 34.21  (10.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 309 participants 611 participants
Female
302
 100.0%
309
 100.0%
611
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient’s Interview at End of Treatment Visit
Hide Description
  • 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description:

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®

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

Overall Number of Participants Analyzed 302 309
Measure Type: Count of Participants
Unit of Measure: Participants
Success
275
  91.1%
268
  86.7%
Failure
27
   8.9%
41
  13.3%
2.Secondary Outcome
Title Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description:

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®

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

Overall Number of Participants Analyzed 302 309
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
Vaginal discharge absolute change
31.43
(29.94 to 32.91)
29.54
(28.07 to 31.01)
Vaginal burning absolute change
27.89
(26.66 to 29.12)
27.03
(25.81 to 28.25)
Vaginal pain absolute change
16.93
(15.86 to 18.01)
17.17
(16.10 to 18.24)
Vaginal irritation absolute change
29.37
(28.06 to 30.67)
28.79
(27.51 to 30.08)
Vaginal combined clinical symptoms score absolute
28.96
(26.79 to 31.14)
28.20
(26.04 to 30.35)
3.Secondary Outcome
Title Number of Patients With Change in Vaginal Discharge Assessed by the Investigator
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description:

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®

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

Overall Number of Participants Analyzed 300 307
Measure Type: Count of Participants
Unit of Measure: Participants
Leucorrhoea score change - Deterioration
1
   0.3%
7
   2.3%
Leucorrhoea score change - No change
19
   6.3%
24
   7.8%
Leucorrhoea score change - Improvement
280
  93.3%
276
  89.9%
4.Secondary Outcome
Title Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient’s Interview at End of Study Visit
Hide Description Success and Failure (same definition as the primary outcome measure)
Time Frame 22 days after first treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
There were 5 and 6 missing values respectively in Polygynax and Miconazole + placebo arms.
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description:

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®

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

Overall Number of Participants Analyzed 302 309
Measure Type: Count of Participants
Unit of Measure: Participants
Success Number Analyzed 297 participants 303 participants
252
  84.8%
250
  82.5%
Failure Number Analyzed 297 participants 303 participants
45
  15.2%
53
  17.5%
5.Secondary Outcome
Title Investigator's Global Satisfaction
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description:

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®

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

Overall Number of Participants Analyzed 300 307
Measure Type: Count of Participants
Unit of Measure: Participants
Very good - Good
265
  88.3%
252
  82.1%
Somewhat good - Somewhat bad
25
   8.3%
40
  13.0%
Bad - Very bad
10
   3.3%
15
   4.9%
6.Secondary Outcome
Title Patient's Global Satisfaction
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
There were 10 and 11 missing values respectively in Polygynax and Miconazole + placebo arms.
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description:

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®

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

Overall Number of Participants Analyzed 292 298
Measure Type: Count of Participants
Unit of Measure: Participants
Very good - Good
239
  81.8%
233
  78.2%
Somewhat good - Somewhat bad
50
  17.1%
63
  21.1%
Bad - Very bad
3
   1.0%
2
   0.7%
Time Frame 22 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title POLYGYNAX® Miconazole + Placebo
Hide Arm/Group Description

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®

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

All-Cause Mortality
POLYGYNAX® Miconazole + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/325 (0.00%)   0/328 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
POLYGYNAX® Miconazole + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/325 (0.31%)   0/328 (0.00%) 
Injury, poisoning and procedural complications     
Patient pregnant exposed to study medications * 1  1/325 (0.31%)  0/328 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
POLYGYNAX® Miconazole + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   18/325 (5.54%)   5/328 (1.52%) 
Nervous system disorders     
Headache * 1  18/325 (5.54%)  5/328 (1.52%) 
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Medical Affairs
Organization: Laboratoire Innotech International
Phone: +33 (0)1 46 15 29 00
Layout table for additonal information
Responsible Party: Laboratoire Innotech International
ClinicalTrials.gov Identifier: NCT02515656     History of Changes
Other Study ID Numbers: PGX 401-11
2014-001759-22 ( EudraCT Number )
First Submitted: July 29, 2015
First Posted: August 5, 2015
Results First Submitted: September 21, 2017
Results First Posted: January 21, 2019
Last Update Posted: January 21, 2019