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

Sponsor
EMS (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT05031481
Collaborator
(none)
0
Enrollment
4
Arms
20
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Venus 20 + 0,064
  • Drug: Venus 20 + 1
  • Drug: Venus 20 + 4
  • Drug: Butoconazole nitrate
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Adverse events [28 days]

    Incidence and severity of adverse events recorded during the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • EMS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EMS
ClinicalTrials.gov Identifier:
NCT05031481
Other Study ID Numbers:
  • EMS1819 - VENUS
First Posted:
Sep 2, 2021
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EMS
Vulvovaginal Candidiasis
Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Butoconazole

Study Results

No Results Posted as of Aug 10, 2022