Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

Sponsor

Aesculape CRO Belgium BV (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04813822

Collaborator

(none)

Enrollment

Locations

Arms

12.6

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

Condition or Disease	Intervention/Treatment	Phase
Acute Vulvovaginal Candidiasis	Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose Drug: Miconazole Nitrate 2%	Phase 2

Detailed Description

Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

Actual Study Start Date :

Sep 13, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.	Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose Dosage 1
Experimental: Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.	Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose Dosage 2
Active Comparator: Gyno-Daktarin® Vaginal Cream The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.	Drug: Miconazole Nitrate 2% Active Comparator

Arm

Intervention/Treatment

Experimental: Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.

Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Dosage 1

Experimental: Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.

Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose

Dosage 2

Active Comparator: Gyno-Daktarin® Vaginal Cream

The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.

Drug: Miconazole Nitrate 2%

Active Comparator

Outcome Measures

Primary Outcome Measures

The proportion of subjects with clinical cure [First follow-up visit (Day 15)]
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
The proportion of subjects with mycological eradication [First follow-up visit (Day 15)]
A culture negative vaginal swab for growth of baseline Candida species
The proportion of subjects with overall therapeutic success [First follow-up visit (Day 15)]
Achievement of both clinical cure and mycological eradication

Secondary Outcome Measures

The proportion of subjects with clinical cure [First follow-up visit through Week 12]
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
The proportion of subjects with mycological eradication [First follow-up visit through Week 12]
A culture negative vaginal swab for growth of baseline Candida species at Day 15, a culture and PCR negative vaginal swab for growth of baseline Candida species on the Other follow-up visits
The proportion of subjects with overall therapeutic success [First follow-up visit through Week 12]
Achievement of both clinical cure and mycological eradication
Change from Baseline in vulvovaginitis symptom questionnaire total score [Through Week 12]
VSQ: Vulvovaginal symptoms questionnaire
Change from Baseline in the EQ-5D questionnaire total score [Through Week 12]
EQ-5D: health-related quality of life questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Main inclusion criteria:

Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit.
Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.

Main exclusion criteria :

Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment.
Subjects with visible condylomas on vulvovaginal examination at Screening Visit.
Subjects with the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of the clinical response.
Subjects with a history of cervical cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Antwerpen - Gynaecology department	Edegem	Antwerpen	Belgium	2650
2	Femicare vzw	Tienen	Brabant	Belgium	3300
3	Fertiliteitscentrum Dr. Decleer Aalter	Aalter	East Flanders	Belgium	9880
4	UZ Gent - Gynaecology department	Gent	East Flanders	Belgium	9000
5	Dr. Goessens - Dr. Houben, Private practice - Gynaecology	Brugge	West Flanders	Belgium	8000
6	Dr. Philip Loquet, Private practice - Gynaecology	Antwerpen		Belgium	2018