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Completed

NCT Number: NCT03064789

Epidemiological Study in Subjects With Vulvovaginal Candidiases

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

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Key information

Conditions

Vulvovaginal Candidiases Bacterial Infections and Mycoses Candidiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Palacios

Madrid, 28009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Estimate recurrences

    Time frame: At 6 months

    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture

  2. Estimate recurrences

    Time frame: At 12 months

    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture

  3. Evaluate the link between symptomatology and negative culture

    Time frame: At 3 months

  4. Evaluate the effectiveness of probiotic treatment by physician

    Time frame: At 3 months

    A gynecological exploration will be performed

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

    Time frame: At 3 months

    The subject will be asked how long the symptoms lasted and the gravity of them

Sponsors and collaborators

Lead sponsor

Dr. Santiago Palacios

Other

Registry information

Official study title

Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2017
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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