Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis

• Sponsor: Instituto Palacios (Other)
• Overall Status: Completed
• CT.gov ID: NCT02248506
• Collaborator: Gynea Laboratorios SA (Other)
• Enrollment: 56
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Vulvovaginal	Other: Clotrimazole	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Clotrimazole Clotrimazole 500 mg	Other: Clotrimazole; All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).

Outcome Measures

Primary Outcome Measures

1. Vaginal swab test [Baseline]

   To verify diagnosis of vaginal candidiasis

2. Vaginal swab test [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

3. Vaginal swab test [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

4. Vaginal swab test [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Palacios	Madrid		Spain	28009

Sponsors and Collaborators

• Instituto Palacios
• Gynea Laboratorios SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto Palacios
• ClinicalTrials.gov Identifier: NCT02248506
• Other Study ID Numbers: GY-LAC-01-2012
• First Posted: Sep 25, 2014
• Last Update Posted: Mar 25, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Instituto Palacios: Candidiasis
• Additional relevant MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Clotrimazole; Miconazole

Study Results

No Results Posted as of Mar 25, 2015