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
About this trial
This is an interventional treatment trial for Vulvovaginal Candidiasis
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.
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
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
background
Learn more about this trial
Comparison of Boric Acid vs. Terconazole in Treatment of RVVC
We'll reach out to this number within 24 hrs