Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (3)

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

Secondary Outcomes (5)

The proportion of subjects with clinical cure
First follow-up visit through Week 12
The proportion of subjects with mycological eradication
First follow-up visit through Week 12
The proportion of subjects with overall therapeutic success
First follow-up visit through Week 12
Change from Baseline in vulvovaginitis symptom questionnaire total score
Through Week 12
Change from Baseline in the EQ-5D questionnaire total score
Through Week 12

Study Arms (3)

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

EXPERIMENTAL

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

Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

EXPERIMENTAL

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

Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose

Gyno-Daktarin® Vaginal Cream

ACTIVE COMPARATOR

Interventions

Miconazole Nitrate 2% + Domiphen Bromide Low DoseDrug

Dosage 1

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

Miconazole Nitrate 2% + Domiphen Bromide High DoseDrug

Dosage 2

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

Eligibility Criteria

Age18 Years - 50 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Aesculape CRO Belgium BV
Industrylead

Study Sites (6)

UZ Antwerpen - Gynaecology department

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Gilbert Donders, Prof. dr.CONTACT

Femicare vzw

Tienen, Brabant, 3300, Belgium

RECRUITING

Gilbert Donders, Prof. Dr.CONTACT

Fertiliteitscentrum Dr. Decleer Aalter

Aalter, East Flanders, 9880, Belgium

RECRUITING

MeSH Terms

Interventions

Miconazoledomiphen

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Jean-Paul Deslypere, MD
Aesculape CRO Belgium BV
STUDY DIRECTOR

Central Study Contacts

Jean-Paul Deslypere, MD

CONTACT

+32492735931 jpdeslypere@aesculape.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 24, 2021

Study Start

September 13, 2021

Actual (reported)

Primary Completion

May 2022

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (3)

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

Gyno-Daktarin® Vaginal Cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (3)

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

Gyno-Daktarin® Vaginal Cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations