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Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

Primary Purpose

Vulvovaginal Candidiasis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Boric Acid Vaginal Suppository
Terconazole Vaginal Suppository
Sponsored by
Hatem AbuHashim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of RVVC will be defined as four or more episodes of VVC that occurred during the previous 12-month period.
  • Has symptoms and signs of VVC e.g. itching, burning, discharge, and erythema.
  • Documented VVC on high vaginal swabs (HVSs) by the demonstration of blastospores and pseudohyphae in a wet vaginal smear treated with 10% potassium hydroxide, and a positive fungal culture.
  • Age: 18-50 years old and premenopausal.
  • Agree to abstain from sexual intercourse during the treatment period.
  • Agree to abstain from using any other vaginal product during the study period.

Exclusion Criteria:

  • Postmenopausal.
  • Pregnancy.
  • Sexually transmitted infection (Chlamydia, gonorrhea, trichomonas).
  • Any antifungal or antibiotic use 14 days prior to treatment.
  • Gynecological conditions requiring treatment e.g. Bartholin's cyst, abscess, PID.
  • Patients receiving corticosteroids or immunosuppressive therapy.
  • Patients expected to menstruate within seven days of the start of treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Boric acid vaginal suppository

    Terconazole vaginal suppository

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mycological cure rate
    Negative Candida by cultures of high vaginal swabs

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2019
    Last Updated
    December 21, 2019
    Sponsor
    Hatem AbuHashim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04208555
    Brief Title
    Comparison of Boric Acid vs. Terconazole in Treatment of RVVC
    Official Title
    A Randomized Comparison of Boric Acid Versus Terconazole in Treatment of Recurrent Vulvovaginal Candidiasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2020 (Anticipated)
    Primary Completion Date
    February 28, 2021 (Anticipated)
    Study Completion Date
    May 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hatem AbuHashim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Vulvovaginal candidiasis (VVC) caused by Candida species, predominantly C. Albicans is considered one of the most common infections of the lower female genital tract affecting 75% of women at least once in their lifetime. Recurrent VVC (RVVC) is arbitrarily defined as four or more episodes every year. RVVC is a debilitating, long-term condition that can severely affect the quality of life of women. Several factors have been associated with RVVC such as prolonged use of antibiotics, inadequately treated infection, uncontrolled diabetes, immune mechanisms (e.g. HIV), oral contraceptive use as well as the resistance of non-albicans Candida species (e.g. C glabrata, C krusei) to conventional antifungal agents as azoles. Fluconazole administered orally is the most commonly used antifungal drug in the case of RVVC. However, in the last decade, fluconazole-resistant C Albicans has been reported in women with RVVC. Terconazole is a broad-spectrum, triazole antifungal treatment agent for both C Albicans and non-albicans. Its use (80 mg vaginal suppository daily for 6 days) was as effective as two doses of oral fluconazole (150 mg) in the treatment of patients with severe VVC and RVVC. Boric acid or boracic [B(OH)3] is a weak acid with proven antifungal action. In RVVC especially in azole-resistant strains and in non-Candida Albicans, 600 mg of the boric acid vaginal suppository is recommended once daily for 2 weeks. This regimen has a mycologic cure rate varied from 40% to 100%. However, there are no published studies comparing the intravaginal use of boric acid with terconazole for RVVC. Accordingly, a prospective randomized study in patients with RVVC will be conducted to address this important issue.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vulvovaginal Candidiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Boric acid vaginal suppository
    Arm Type
    Experimental
    Arm Title
    Terconazole vaginal suppository
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Boric Acid Vaginal Suppository
    Intervention Description
    Boric acid vaginal suppository (600 mg/day) for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Terconazole Vaginal Suppository
    Intervention Description
    Terconazole 80 mg vaginal suppository daily for 6 days
    Primary Outcome Measure Information:
    Title
    Mycological cure rate
    Description
    Negative Candida by cultures of high vaginal swabs
    Time Frame
    At day 15 of treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of RVVC will be defined as four or more episodes of VVC that occurred during the previous 12-month period. Has symptoms and signs of VVC e.g. itching, burning, discharge, and erythema. Documented VVC on high vaginal swabs (HVSs) by the demonstration of blastospores and pseudohyphae in a wet vaginal smear treated with 10% potassium hydroxide, and a positive fungal culture. Age: 18-50 years old and premenopausal. Agree to abstain from sexual intercourse during the treatment period. Agree to abstain from using any other vaginal product during the study period. Exclusion Criteria: Postmenopausal. Pregnancy. Sexually transmitted infection (Chlamydia, gonorrhea, trichomonas). Any antifungal or antibiotic use 14 days prior to treatment. Gynecological conditions requiring treatment e.g. Bartholin's cyst, abscess, PID. Patients receiving corticosteroids or immunosuppressive therapy. Patients expected to menstruate within seven days of the start of treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hatem Abu Hashim, MD.FRCOG.PhD
    Phone
    +20502300002
    Email
    hatem_ah@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hatem Abu Hashim, MD. FRCOG. PhD
    Organizational Affiliation
    Faculty of Medicine, Mansoura University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Asmaa Swidan, MBBCh
    Organizational Affiliation
    New Mansoura General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21774671
    Citation
    Iavazzo C, Gkegkes ID, Zarkada IM, Falagas ME. Boric acid for recurrent vulvovaginal candidiasis: the clinical evidence. J Womens Health (Larchmt). 2011 Aug;20(8):1245-55. doi: 10.1089/jwh.2010.2708. Epub 2011 Jul 20.
    Results Reference
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    Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

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