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Diabetes Mellitus and Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT00353561
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : May 22, 2008
Sponsor:
Information provided by:
Indian Council of Medical Research

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Vulvovaginal Candidiasis Drug: Boric Drug: Fluconazole Phase 3

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Mellitus and Vulvovaginal Candidiasis: Prevalence of Infection and Its Rationale Management
Study Start Date : June 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

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

2, Fluconazole Drug: Fluconazole
150 mg oral fluconazole gives once in 14 days




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Relief in clinical symptoms and signs of vulvovaginal candidiasis including vaginal discharge, pruritus, burning sensation and vaginal congestion [ Time Frame: 15 days ]


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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Genital Diseases, Female
Diabetes Mellitus
Candidiasis
Candidiasis, Vulvovaginal
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors