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

Vulvovaginal Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05031481
• Other study ID #: EMS1819 - VENUS
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: August 2022
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Venus 20 + 0,064
Venus vaginal cream 20 + 0,064, single-dose.
• Venus 20 + 1
Venus vaginal cream 20 + 1, single-dose.
• Venus 20 + 4
Venus vaginal cream 20 + 4, single-dose.
• Butoconazole nitrate
Butoconazole nitrate vaginal cream, 100 mg single-dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

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