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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05031481

Enrollment

Registered

2021-09-02

Start date

2022-07-01

Completion date

2024-03-31

Last updated

2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal Candidiasis

Keywords

Vulvovaginal Candidiasis

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.

Interventions

DRUGVenus 20 + 0,064

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

DRUGVenus 20 + 1

Venus vaginal cream 20 + 1, single-dose.

DRUGVenus 20 + 4

Venus vaginal cream 20 + 4, single-dose.

DRUGButoconazole nitrate

Butoconazole nitrate vaginal cream, 100 mg single-dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026