Vulvovaginal Candidiases Clinical Trial
Official title:
Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal
NCT number | NCT03064789 |
Other study ID # | IP-01-2016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 29, 2016 |
Est. completion date | June 30, 2019 |
Verified date | February 2021 |
Source | Instituto Palacios |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody
Status | Completed |
Enrollment | 43 |
Est. completion date | June 30, 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Sexually active women between 18 and 50 years of age at time of screening - With diagnosis and symptomatology of VVC Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Palacios | Madrid |
Lead Sponsor | Collaborator |
---|---|
Dr. Santiago Palacios |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate cure rate in women with severe vuvovaginal candidiases infection | Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards | At 3 months | |
Secondary | Estimate recurrences | It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture | At 6 months | |
Secondary | Estimate recurrences | It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture | At 12 months | |
Secondary | Evaluate the link between symptomatology and negative culture | At 3 months | ||
Secondary | Evaluate the effectiveness of probiotic treatment by physician | A gynecological exploration will be performed | At 3 months | |
Secondary | 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 | At 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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