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

Aesculape CRO

Status and phase: Unknown; Phase 2

Conditions: Acute Vulvovaginal Candidiasis

Treatments: Drug: Miconazole Nitrate 2%; Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose; Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04813822

FHP-2021-2-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria:

1. Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit.
2. 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 :

1. Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment.
2. Subjects with visible condylomas on vulvovaginal examination at Screening Visit.
3. 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.
4. Subjects with a history of cervical cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream

Experimental group

Description:

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

Treatment:

Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose

Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream

Experimental group

Description:

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

Treatment:

Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose

Gyno-Daktarin® Vaginal Cream

Active Comparator group

Description:

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

Treatment:

Drug: Miconazole Nitrate 2%