Vulvovaginal CandidiasisPhase 2NCT05031481
Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.
A Phase 2 study testing Venus 20 + 0,064, Venus 20 + 1 and Venus 20 + 4 in people with Vulvovaginal Candidiasis, run by EMS.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Venus 20 + 0,064, Venus 20 + 1 and Venus 20 + 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Participants with other vaginal infections;
- Participants with recurrent vulvovaginal candidiasis;
- Participants using immunosuppressive drugs;
- Participants diagnosed with serious systemic diseases.
About this study
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
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
- Being tested
- Venus 20 + 0,064, Venus 20 + 1, Venus 20 + 4, Butoconazole nitrate
- Keywords
- Vulvovaginal Candidiasis
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus 20 + 0,064Drug
Venus vaginal cream 20 + 0,064, single-dose.
Venus 20 + 1Drug
Venus vaginal cream 20 + 1, single-dose.
Venus 20 + 4Drug
Venus vaginal cream 20 + 4, single-dose.
Butoconazole nitrateDrug
Butoconazole nitrate vaginal cream, 100 mg single-dose.
| Study group | Role | What they receive |
|---|---|---|
| VENUS 20 + 0,064 | Experimental | Venus association vaginal cream, single dose. Receives: Drug: Venus 20 + 0,064 |
| VENUS 20 + 1 | Experimental | Venus association vaginal cream, single dose. Receives: Drug: Venus 20 + 1 |
| VENUS 20 + 4 | Experimental | Venus association vaginal cream, single dose. Receives: Drug: Venus 20 + 4 |
| Butoconazole nitrate 100 mg | Active comparator | Butoconazole nitrate vaginal cream, single-dose containing 100 mg. Receives: Drug: Butoconazole nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-24 hours
Secondary outcomes (1)
Adverse events
Incidence and severity of adverse events recorded during the study.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jul 2022
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031481
- Sponsor's protocol ID
- EMS1819 - VENUS
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05031481
- Acronym / sponsor ID
- EMS1819 - VENUS
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- Vulvovaginal Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of different doses of Venus association in the treatment of vulvovaginal candidiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VENUS 20 + 0,064 | Experimental | Drug: Venus 20 + 0,064Venus association vaginal cream, single dose. |
| VENUS 20 + 1 | Experimental | Drug: Venus 20 + 1Venus association vaginal cream, single dose. |
| VENUS 20 + 4 | Experimental | Drug: Venus 20 + 4Venus association vaginal cream, single dose. |
| Butoconazole nitrate 100 mg | Active comparator | Drug: Butoconazole nitrateButoconazole nitrate vaginal cream, single-dose containing 100 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venus 20 + 0,064Venus vaginal cream 20 + 0,064, single-dose. | Drug | VENUS 20 + 0,064 |
| Venus 20 + 1Venus vaginal cream 20 + 1, single-dose. | Drug | VENUS 20 + 1 |
| Venus 20 + 4Venus vaginal cream 20 + 4, single-dose. | Drug | VENUS 20 + 4 |
| Butoconazole nitrateButoconazole nitrate vaginal cream, 100 mg single-dose. | Drug | Butoconazole nitrate 100 mg |
Primary outcome
Time to first relief of symptoms
Time frame: 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.
1 secondary outcome
Adverse events
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venus 20 + 0,064, Venus 20 + 1 and Venus 20 + 4 in people with Vulvovaginal Candidiasis, run by EMS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first relief of symptoms (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.