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

Primary Purpose

Acute Vulvovaginal Candidiasis

Status

Recruiting

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Miconazole Nitrate 2% + Domiphen Bromide High Dose

Miconazole Nitrate 2%

About this trial

This is an interventional treatment trial for Acute Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

UZ Antwerpen - Gynaecology departmentRecruiting
Femicare vzwRecruiting
Fertiliteitscentrum Dr. Decleer AalterRecruiting
UZ Gent - Gynaecology departmentRecruiting
Dr. Goessens - Dr. Houben, Private practice - GynaecologyRecruiting
Dr. Philip Loquet, Private practice - GynaecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

Gyno-Daktarin® Vaginal Cream

Arm Description

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

Outcomes

Primary Outcome Measures

The proportion of subjects with clinical cure

Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)

The proportion of subjects with mycological eradication

A culture negative vaginal swab for growth of baseline Candida species

The proportion of subjects with overall therapeutic success

Achievement of both clinical cure and mycological eradication

Secondary Outcome Measures

The proportion of subjects with clinical cure

Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)

The proportion of subjects with mycological eradication

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

Achievement of both clinical cure and mycological eradication

Change from Baseline in vulvovaginitis symptom questionnaire total score

VSQ: Vulvovaginal symptoms questionnaire

Change from Baseline in the EQ-5D questionnaire total score

EQ-5D: health-related quality of life questionnaire

Full Information

NCT ID

NCT04813822

First Posted

March 10, 2021

Last Updated

March 11, 2022

Sponsor

Aesculape CRO Belgium BV

1. Study Identification

Unique Protocol Identification Number

NCT04813822

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 13, 2021 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aesculape CRO Belgium BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Vulvovaginal Candidiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

Arm Type

Experimental

Arm Description

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

Arm Title

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

Arm Type

Experimental

Arm Description

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

Arm Title

Gyno-Daktarin® Vaginal Cream

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Intervention Description

Dosage 1

Intervention Type

Drug

Intervention Name(s)

Miconazole Nitrate 2% + Domiphen Bromide High Dose

Intervention Description

Dosage 2

Intervention Type

Drug

Intervention Name(s)

Miconazole Nitrate 2%

Intervention Description

Active Comparator

Primary Outcome Measure Information:

Title

The proportion of subjects with clinical cure

Description

Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)

Time Frame

First follow-up visit (Day 15)

Title

The proportion of subjects with mycological eradication

Description

A culture negative vaginal swab for growth of baseline Candida species

Time Frame

First follow-up visit (Day 15)

Title

The proportion of subjects with overall therapeutic success

Description

Achievement of both clinical cure and mycological eradication

Time Frame

First follow-up visit (Day 15)

Secondary Outcome Measure Information:

Title

The proportion of subjects with clinical cure

Description

Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)

Time Frame

First follow-up visit through Week 12

Title

The proportion of subjects with mycological eradication

Description

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

Time Frame

First follow-up visit through Week 12

Title

The proportion of subjects with overall therapeutic success

Description

Achievement of both clinical cure and mycological eradication

Time Frame

First follow-up visit through Week 12

Title

Change from Baseline in vulvovaginitis symptom questionnaire total score

Description

VSQ: Vulvovaginal symptoms questionnaire

Time Frame

Through Week 12

Title

Change from Baseline in the EQ-5D questionnaire total score

Description

EQ-5D: health-related quality of life questionnaire

Time Frame

Through Week 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Paul Deslypere, MD

Phone

+32492735931

jpdeslypere@aesculape.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Paul Deslypere, MD

Organizational Affiliation

Aesculape CRO Belgium BV

Official's Role

Study Director

Facility Information:

Facility Name

UZ Antwerpen - Gynaecology department

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilbert Donders, Prof. dr.

Facility Name

Femicare vzw

City

Tienen

State/Province

Brabant

ZIP/Postal Code

3300

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilbert Donders, Prof. Dr.

Facility Name

Fertiliteitscentrum Dr. Decleer Aalter

City

Aalter

State/Province

East Flanders

ZIP/Postal Code

9880

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wim Decleer, MD

Facility Name

UZ Gent - Gynaecology department

City

Gent

State/Province

East Flanders

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hans Verstraelen, Prof. Dr.

Facility Name

Dr. Goessens - Dr. Houben, Private practice - Gynaecology

City

Brugge

State/Province

West Flanders

ZIP/Postal Code

8000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luc Goessens, MD

Facility Name

Dr. Philip Loquet, Private practice - Gynaecology

City

Antwerpen

ZIP/Postal Code

2018

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philip Loquet, Dr.

12. IPD Sharing Statement

Learn more about this trial

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

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