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

Primary Purpose

Vulvovaginal Candidiasis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Venus 20 + 0,064

Venus 20 + 1

Venus 20 + 4

Butoconazole nitrate

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

VENUS 20 + 0,064

VENUS 20 + 1

VENUS 20 + 4

Butoconazole nitrate 100 mg

Arm Description

Venus association vaginal cream, single dose.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events

Incidence and severity of adverse events recorded during the study.

Full Information

NCT ID

NCT05031481

First Posted

August 26, 2021

Last Updated

August 8, 2022

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT05031481

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor decision

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Candidiasis

Keywords

Vulvovaginal Candidiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VENUS 20 + 0,064

Arm Type

Experimental

Arm Description

Venus association vaginal cream, single dose.

Arm Title

VENUS 20 + 1

Arm Type

Experimental

Arm Description

Venus association vaginal cream, single dose.

Arm Title

VENUS 20 + 4

Arm Type

Experimental

Arm Description

Venus association vaginal cream, single dose.

Arm Title

Butoconazole nitrate 100 mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Venus 20 + 0,064

Intervention Description

Venus vaginal cream 20 + 0,064, single-dose.

Intervention Type

Drug

Intervention Name(s)

Venus 20 + 1

Intervention Description

Venus vaginal cream 20 + 1, single-dose.

Intervention Type

Drug

Intervention Name(s)

Venus 20 + 4

Intervention Description

Venus vaginal cream 20 + 4, single-dose.

Intervention Type

Drug

Intervention Name(s)

Butoconazole nitrate

Intervention Description

Butoconazole nitrate vaginal cream, 100 mg single-dose.

Primary Outcome Measure Information:

Title

Time to first relief of symptoms

Description

Time to obtain moderate relief of at least one of the evaluated symptoms (itching, irritation or burning) after the application of the medication.

Time Frame

0-24 hours

Secondary Outcome Measure Information:

Title

Adverse events

Description

Incidence and severity of adverse events recorded during the study.

Time Frame

28 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

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