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

NCT05031481 | Withdrawn Phase 2 DMC

• 1 other identifier: EMS1819 - VENUS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvovaginal Candidiasis

Keywords

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  28 days

Study Arms (4)

VENUS 20 + 0,064

EXPERIMENTAL

Venus association vaginal cream, single dose.

Drug: Venus 20 + 0,064

VENUS 20 + 1

EXPERIMENTAL

Venus association vaginal cream, single dose.

Drug: Venus 20 + 1

VENUS 20 + 4

EXPERIMENTAL

Venus association vaginal cream, single dose.

Drug: Venus 20 + 4

Butoconazole nitrate 100 mg

ACTIVE COMPARATOR

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

Drug: Butoconazole nitrate

Interventions

Venus 20 + 0,064 DRUG

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

VENUS 20 + 0,064

Venus 20 + 1 DRUG

Venus vaginal cream 20 + 1, single-dose.

VENUS 20 + 1

Venus 20 + 4 DRUG

Venus vaginal cream 20 + 4, single-dose.

VENUS 20 + 4

Butoconazole nitrate DRUG

Butoconazole nitrate vaginal cream, 100 mg single-dose.

Butoconazole nitrate 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

butoconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-08