Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.

EMS

Status and phase: Withdrawn; Phase 2

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: Butoconazole nitrate; Drug: Venus 20 + 0,064; Drug: Venus 20 + 4; Drug: Venus 20 + 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05031481

EMS1819 - VENUS

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of different doses of Venus association in the treatment of vulvovaginal candidiasis.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Age greater than or equal to 18 years;
• Female participants, post-menarche;
• Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings:
• Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation;
• Normal vaginal pH;
• Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast.

Exclusion criteria

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Participation in a clinical trial in the year prior to this study;
• Pregnancy or risk of pregnancy and lactating patients;
• Known hypersensitivity to any of the formula compounds;
• Virgin participants;
• Postmenopausal participants or with vaginal atrophy;
• Participants with other vaginal infections;
• Participants with recurrent vulvovaginal candidiasis;
• Participants using immunosuppressive drugs;
• Participants diagnosed with serious systemic diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

VENUS 20 + 0,064

Experimental group

Description:

Venus association vaginal cream, single dose.

Treatment:

Drug: Venus 20 + 0,064

VENUS 20 + 1

Experimental group

Description:

Venus association vaginal cream, single dose.

Treatment:

Drug: Venus 20 + 1

VENUS 20 + 4

Experimental group

Description:

Venus association vaginal cream, single dose.

Treatment:

Drug: Venus 20 + 4

Butoconazole nitrate 100 mg

Active Comparator group

Description:

Butoconazole nitrate vaginal cream, single-dose containing 100 mg.

Treatment:

Drug: Butoconazole nitrate