Vulvovaginal CandidiasesNCT03064789
Epidemiological Study in Subjects With Vulvovaginal Candidiases
An observational study of Vulvovaginal Candidiases, run by Dr. Santiago Palacios at 1 site in Spain.
Trial summary
Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vulvovaginal Candidiases
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 29 Dec 2016to 30 Jun 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: Women with VVC symptomatology and positive culture
Who may be able to join
- Sexually active women between 18 and 50 years of age at time of screening
- With diagnosis and symptomatology of VVC
Who cannot join
- Pregnant women
- Diabetes Mellitus
- Women witihin three months after a delivery or misbirth
- Women with vaginal or genital infection symptomatology other than candidiases that needs antibiotic treatment
- Vaginal probiotics use within last three months
- Undiagnosed abnormal genital hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal
Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody
- Conditions
- Vulvovaginal Candidiases
- Keywords
- Candidiases, Vaginal Infections
- Medical subject headings
- Candidiasis, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with candidiases infection | Women that are prescribed treatment with clotrimazole: 500 mg. and probiotics (routine clinical practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate cure rate in women with severe vuvovaginal candidiases infection
Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards
Measured: At 3 months
Secondary outcomes (5)
Estimate recurrences
It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture
Measured: At 6 months
Estimate recurrences
It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture
Measured: At 12 months
Evaluate the link between symptomatology and negative culture
Measured: At 3 months
Evaluate the effectiveness of probiotic treatment by physician
A gynecological exploration will be performed
Measured: At 3 months
Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed
The subject will be asked how long the symptoms lasted and the gravity of them
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start29 Dec 2016
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Santiago Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Santiago Palacios, Instituto Palacios
- Investigators
- Santiago Palacios, PI, Principal investigator, Instituto Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064789
- Sponsor's protocol ID
- IP-01-2016
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2017
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal
- ClinicalTrials.gov ID
- NCT03064789
- Acronym / sponsor ID
- IP-01-2016
- Conditions
- Vulvovaginal Candidiases
- Keywords
- Candidiases, Vaginal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dr. Santiago PalaciosUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Feb 2017 (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.
Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with candidiases infection | – | –Women that are prescribed treatment with clotrimazole: 500 mg. and probiotics (routine clinical practice) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with VVC symptomatology and positive culture
Key inclusion criteria (2 listed)
- Sexually active women between 18 and 50 years of age at time of screening
- With diagnosis and symptomatology of VVC
Key exclusion criteria (6 listed)
- Pregnant women
- Diabetes Mellitus
- Women witihin three months after a delivery or misbirth
- Women with vaginal or genital infection symptomatology other than candidiases that needs antibiotic treatment
- Vaginal probiotics use within last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate cure rate in women with severe vuvovaginal candidiases infection
Time frame: At 3 months
Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards
5 secondary outcomes
Estimate recurrences
Time frame: At 6 months
Estimate recurrences
Time frame: At 12 months
Evaluate the link between symptomatology and negative culture
Time frame: At 3 months
Evaluate the effectiveness of probiotic treatment by physician
Time frame: At 3 months
Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed
Time frame: At 3 months
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 11 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Santiago Palacios, PI principal investigator
Instituto Palacios
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Candidiases, run by Dr. Santiago 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 2 inclusion and 6 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 11 Feb 2021. 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.
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?
Estimate cure rate in women with severe vuvovaginal candidiases infection (time frame: At 3 months). 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 11 Feb 2021.