NCT03064789

Brief Summary

Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

February 10, 2017

Last Update Submit

February 10, 2021

Conditions

Vulvovaginal Candidiases

Keywords

CandidiasesVaginal Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Estimate recurrences

    At 6 months

  • Estimate recurrences

    At 12 months

  • Evaluate the link between symptomatology and negative culture

    At 3 months

  • Evaluate the effectiveness of probiotic treatment by physician

    At 3 months

  • Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed

    At 3 months

Study Arms (1)

Women with candidiases infection

Women that are prescribed treatment with clotrimazole: 500 mg. and probiotics (routine clinical practice)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with VVC symptomatology and positive culture

You may qualify if:

  • Sexually active women between 18 and 50 years of age at time of screening
  • With diagnosis and symptomatology of VVC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

CandidiasisVaginitis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Santiago Palacios, PI

    Instituto Palacios

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD - Gynecologyst

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 27, 2017

Study Start

December 29, 2016

Primary Completion

March 30, 2019

Study Completion

June 30, 2019

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)