Candidiasis, VulvovaginalPhase 4NCT02248506
Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
A Phase 4 study testing Clotrimazole in people with Candidiasis, Vulvovaginal, run by Instituto Palacios at 1 site in Spain.
Trial summary
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Clotrimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Mar 2015
- Phase
- Phase 4
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sexually active women between 18 and 50 years
- Patients attending to the gynecologist with acute vulvovaginal candidiasis.
- Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study.
- Women who agree to participate in the study and has signed the informed consent sheet.
Who cannot join
- Use of any medication that may interfere significantly with study assessments.
- Pregnant or breastfeeding
- Women with signs of other genital infection
- Within 3 months after childbirth or abortion
- Patients that is expected not to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Clotrimazole
- Keywords
- Candidiasis
- Medical subject headings
- Candidiasis, Vulvovaginal, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotrimazoleOther
All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole | Other | Clotrimazole 500 mg Receives: Other: Clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal swab test
To verify diagnosis of vaginal candidiasis
Measured: Baseline
Vaginal swab test
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Measured: month 2
Vaginal swab test
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Measured: month 3
Vaginal swab test
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Collaborators
- Gynea Laboratorios SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248506
- Sponsor's protocol ID
- GY-LAC-01-2012
- Status last verified
- Mar 2015
- First submitted
- 18 Sep 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
- ClinicalTrials.gov ID
- NCT02248506
- Acronym / sponsor ID
- GY-LAC-01-2012
- Conditions
- Candidiasis, Vulvovaginal
- Keywords
- Candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Collaborators
- Gynea Laboratorios SA
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole | Other | Other: ClotrimazoleClotrimazole 500 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sexually active women between 18 and 50 years
- Patients attending to the gynecologist with acute vulvovaginal candidiasis.
- Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study.
- Women who agree to participate in the study and has signed the informed consent sheet.
Key exclusion criteria (5 listed)
- Use of any medication that may interfere significantly with study assessments.
- Pregnant or breastfeeding
- Women with signs of other genital infection
- Within 3 months after childbirth or abortion
- Patients that is expected not to attend follow-up visits
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 |
|---|---|---|
| ClotrimazoleAll patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment). | Other | Clotrimazole |
Primary outcome
Vaginal swab test
Time frame: Baseline
To verify diagnosis of vaginal candidiasis
Vaginal swab test
Time frame: month 2
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Vaginal swab test
Time frame: month 3
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Vaginal swab test
Time frame: month 6
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clotrimazole in people with Candidiasis, Vulvovaginal, run by Instituto Palacios at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaginal swab test (time frame: Baseline). The study lists 4 primary outcomes in all. 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 25 Mar 2015.