Trial Outcomes & Findings for Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis (NCT NCT02515656)

NCT ID: NCT02515656

Last Updated: 2019-01-22

Results Overview

* 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 661 participants
• Primary outcome timeframe: 15 days after first treatment administration
• Results posted on: 2019-01-22

Participant Flow

3 patients who signed an Informed Consent Form (ICF) were screen failed and were not randomized in the study.

Participant milestones

Measure	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®	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
Overall Study STARTED	326	332
Overall Study Full Analysis Set (FAS)	302	309
Overall Study Per Protocol Set (PPS)	277	275
Overall Study Safety Population	325	328
Overall Study COMPLETED	270	261
Overall Study NOT COMPLETED	56	71

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	POLYGYNAX® n=302 Participants 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®	Miconazole + Placebo n=309 Participants 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 n=611 Participants Total of all reporting groups
Age, Continuous	34.70 years STANDARD_DEVIATION 10.13 • n=5 Participants	33.73 years STANDARD_DEVIATION 10.07 • n=7 Participants	34.21 years STANDARD_DEVIATION 10.11 • n=5 Participants
Sex: Female, Male Female	302 Participants n=5 Participants	309 Participants n=7 Participants	611 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	POLYGYNAX® n=302 Participants 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®	Miconazole + Placebo n=309 Participants 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
Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit Success	275 Participants	268 Participants
Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit Failure	27 Participants	41 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	POLYGYNAX® n=302 Participants 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®	Miconazole + Placebo n=309 Participants 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
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 Interval 29.94 to 32.91	29.54 mm Interval 28.07 to 31.01
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 Interval 26.66 to 29.12	27.03 mm Interval 25.81 to 28.25
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 Interval 15.86 to 18.01	17.17 mm Interval 16.1 to 18.24
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 Interval 28.06 to 30.67	28.79 mm Interval 27.51 to 30.08
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 Interval 26.79 to 31.14	28.20 mm Interval 26.04 to 30.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	POLYGYNAX® n=300 Participants 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®	Miconazole + Placebo n=307 Participants 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
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator Leucorrhoea score change - Deterioration	1 Participants	7 Participants
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator Leucorrhoea score change - No change	19 Participants	24 Participants
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator Leucorrhoea score change - Improvement	280 Participants	276 Participants

SECONDARY outcome

Timeframe: 22 days after first treatment administration

Population: There were 5 and 6 missing values respectively in Polygynax and Miconazole + placebo arms.

Success and Failure (same definition as the primary outcome measure)

Outcome measures

Measure	POLYGYNAX® n=302 Participants 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®	Miconazole + Placebo n=309 Participants 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
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	250 Participants
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	53 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	POLYGYNAX® n=300 Participants 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®	Miconazole + Placebo n=307 Participants 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
Investigator's Global Satisfaction Very good - Good	265 Participants	252 Participants
Investigator's Global Satisfaction Somewhat good - Somewhat bad	25 Participants	40 Participants
Investigator's Global Satisfaction Bad - Very bad	10 Participants	15 Participants

SECONDARY outcome

Timeframe: 15 days after first administration

Population: There were 10 and 11 missing values respectively in Polygynax and Miconazole + placebo arms.

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.

Outcome measures

Measure	POLYGYNAX® n=292 Participants 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®	Miconazole + Placebo n=298 Participants 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
Patient's Global Satisfaction Somewhat good - Somewhat bad	50 Participants	63 Participants
Patient's Global Satisfaction Very good - Good	239 Participants	233 Participants
Patient's Global Satisfaction Bad - Very bad	3 Participants	2 Participants

Adverse Events

POLYGYNAX®

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Miconazole + Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	POLYGYNAX® n=325 participants at risk 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®	Miconazole + Placebo n=328 participants at risk 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
Injury, poisoning and procedural complications Patient pregnant exposed to study medications	0.31% 1/325 • 22 days	0.00% 0/328 • 22 days

Other adverse events

Measure	POLYGYNAX® n=325 participants at risk 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®	Miconazole + Placebo n=328 participants at risk 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
Nervous system disorders Headache	5.5% 18/325 • 22 days	1.5% 5/328 • 22 days

Additional Information

Director of Medical Affairs

Laboratoire Innotech International

Phone: +33 (0)1 46 15 29 00

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place