CClinicalTrials.gg
WithdrawnNCT05031481Updated Aug 10, 2022

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

A Phase 2 interventional study of Venus 20 + 0,064 and Venus 20 + 1 in Vulvovaginal Candidiasis, sponsored by EMS. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by EMS · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Vulvovaginal Candidiasis

Keywords

  • Vulvovaginal Candidiasis
03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

Browse Candidiasis studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    VENUS 20 + 0,064

    Venus association vaginal cream, single dose.

    Drug: Venus 20 + 0,064

  • Experimental
    VENUS 20 + 1

    Venus association vaginal cream, single dose.

    Drug: Venus 20 + 1

  • Experimental
    VENUS 20 + 4

    Venus association vaginal cream, single dose.

    Drug: Venus 20 + 4

  • Active comparator
    Butoconazole nitrate 100 mg

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

    Drug: Butoconazole nitrate

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.

06

What researchers measure

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.

    Time frame: 0-24 hours

Secondary outcomes

  1. Adverse events

    Incidence and severity of adverse events recorded during the study.

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05031481
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Sep 2, 2021
Start date
Jul 1, 2022
Primary completion
Dec 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Aug 10, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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