Diabetes Mellitus and Vulvovaginal Candidiasis - Full Text View

Sponsor:	Indian Council of Medical Research
Information provided by:	Indian Council of Medical Research
ClinicalTrials.gov Identifier:	NCT00353561

Purpose

Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.

Condition	Intervention	Phase
Diabetes Mellitus Vulvovaginal Candidiasis	Drug: Boric Drug: Fluconazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Yeast Infections

Drug Information available for: Boric acid Fluconazole

U.S. FDA Resources

Further study details as provided by Indian Council of Medical Research:

Primary Outcome Measures:

Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	June 2004
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1, Boric acid 600 mg vaginal pessaries for 14 days	Drug: Boric Gelatin capsules filled with 600 mg of boric acid
2, Fluconazole	Drug: Fluconazole 150 mg oral fluconazole gives once in 14 days

Detailed Description:

A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Consecutive patients with diabetes mellitus attending Endocrine OPD of All India Institute of Medical Sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of Candida species on culture of high vaginal swab (HVS).

Exclusion Criteria:

Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded.
Subjects also excluded were those with pregnancy,
Sexually inactive girls,
Age > 65 years, renal failure and steroid therapy.
Patients who did not give consent for pelvic examination,
Those who were treated for any kind of vaginal discharge during the past three months and who did not comply with boric acid therapy or did not report on 15th day for repeat examination excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353561

Locations

India
Dr Ravinder Goswami
Delhi, India, 29

Sponsors and Collaborators

Indian Council of Medical Research

Investigators

Principal Investigator:

Ravinder Goswami, DM

All India Institute of Medical Sciences New Delhi, 110029, India

More Information

Additional Information:

PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ravinder Goswami, All India Institute of Medical Sciences, New Delhi 110029
ClinicalTrials.gov Identifier:	NCT00353561 History of Changes
Other Study ID Numbers:	RHN/Adhoc/23/2003-2004
Study First Received:	July 17, 2006
Last Updated:	May 21, 2008
Health Authority:	India: Institutional Review Board

Additional relevant MeSH terms:

Candidiasis
Diabetes Mellitus
Candidiasis, Vulvovaginal
Mycoses
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female

Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012