Diabetes Mellitus and Vulvovaginal Candidiasis

Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Boric; Drug: Fluconazole

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi, India, 29
    • Dr Ravinder Goswami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1, Boric acid; 600 mg vaginal pessaries for 14 days	Drug: Boric; Gelatin capsules filled with 600 mg of boric acid
Other: 2, Fluconazole	Drug: Fluconazole; 150 mg oral fluconazole gives once in 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mycological cure on the 15th day of therapy and defined as the absence of Candida growth on fungal culture of high vaginal swab	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion	15 days

Collaborators and Investigators

• Sponsor: Indian Council of Medical Research
• Investigators: Principal Investigator: Ravinder Goswami, DM, All India Institute of Medical Sciences New Delhi, 110029, India

Publications and helpful links

Helpful Links

• PMID: 17692922 and 17259500, J Infection 2007 and Diabetes Care 2007

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: July 17, 2006
• First Submitted That Met QC Criteria: July 17, 2006
• First Posted (Estimate): July 18, 2006

Study Record Updates

• Last Update Posted (Estimate): May 22, 2008
• Last Update Submitted That Met QC Criteria: May 21, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Infections; Endocrine System Diseases; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Diabetes Mellitus; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: RHN/Adhoc/23/2003-2004