UnknownPhase 2

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

Belgium90 participantsStarted 2021-09-13

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

The proportion of subjects with clinical cure

Timeframe: First follow-up visit (Day 15)

The proportion of subjects with mycological eradication

Timeframe: First follow-up visit (Day 15)

The proportion of subjects with overall therapeutic success

Timeframe: First follow-up visit (Day 15)

Trial details

NCT IDNCT04813822

SponsorAesculape CRO Belgium BV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05

Contact for this trial

Jean-Paul Deslypere, MD

+32492735931 jpdeslypere@aesculape.com

View on ClinicalTrials.gov More Acute Vulvovaginal Candidiasis trials

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.