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

National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis

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

Study Overview

• Status: Withdrawn
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Venus 20 + 0,064; Drug: Venus 20 + 1; Drug: Venus 20 + 4; Drug: Butoconazole nitrate

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VENUS 20 + 0,064; Venus association vaginal cream, single dose.	Drug: Venus 20 + 0,064; Venus vaginal cream 20 + 0,064, single-dose.
Experimental: VENUS 20 + 1; Venus association vaginal cream, single dose.	Drug: Venus 20 + 1; Venus vaginal cream 20 + 1, single-dose.
Experimental: VENUS 20 + 4; Venus association vaginal cream, single dose.	Drug: Venus 20 + 4; Venus vaginal cream 20 + 4, single-dose.
Active Comparator: Butoconazole nitrate 100 mg; Butoconazole nitrate vaginal cream, single-dose containing 100 mg.	Drug: Butoconazole nitrate; Butoconazole nitrate vaginal cream, 100 mg single-dose.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence and severity of adverse events recorded during the study.	28 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Vulvovaginal Candidiasis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Anti-Infective Agents; Antifungal Agents; Butoconazole
• Other Study ID Numbers: EMS1819 - VENUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No