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

Phase 2

Withdrawn

• Conditions: Vulvovaginal Candidiasis
• Interventions: Drug: Butoconazole nitrate; Drug: Venus 20 + 0,064; Drug: Venus 20 + 1; Drug: Venus 20 + 4

• Registration Number: NCT05031481
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-02
• Study Start: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butoconazole nitrate 100 mg	Butoconazole nitrate	Butoconazole nitrate vaginal cream, single-dose containing 100 mg.
VENUS 20 + 0,064	Venus 20 + 0,064	Venus association vaginal cream, single dose.
VENUS 20 + 1	Venus 20 + 1	Venus association vaginal cream, single dose.
VENUS 20 + 4	Venus 20 + 4	Venus association vaginal cream, single dose.

Primary Outcome Measures

Name	Time	Method
Time to first relief of symptoms	0-24 hours	Time to obtain moderate relief of at least one of the evaluated symptoms (itching, irritation or burning) after the application of the medication.

Secondary Outcome Measures

Name	Time	Method
Adverse events	28 days	Incidence and severity of adverse events recorded during the study.