Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

NCT04208555 | Unknown

• 1 other identifier: MS.19.09.825
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• Mycological cure rate

  Negative Candida by cultures of high vaginal swabs

  At day 15 of treatment

Study Arms (2)

Boric acid vaginal suppository

EXPERIMENTAL

Drug: Boric Acid Vaginal Suppository

Terconazole vaginal suppository

ACTIVE COMPARATOR

Drug: Terconazole Vaginal Suppository

Interventions

Boric Acid Vaginal Suppository DRUG

Boric acid vaginal suppository (600 mg/day) for 14 days

Boric acid vaginal suppository

Terconazole Vaginal Suppository DRUG

Terconazole 80 mg vaginal suppository daily for 6 days

Terconazole vaginal suppository

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatem AbuHashim: lead

Related Publications (1)

• 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.

  PMID: 21774671 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Hatem Abu Hashim, MD. FRCOG. PhD

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

• Asmaa Swidan, MBBCh

  New Mansoura General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatem Abu Hashim, MD.FRCOG.PhD

CONTACT

+20502300002; hatem_ah@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 15, 2020
• Primary Completion: February 28, 2021
• Study Completion: May 31, 2021
• Last Updated: December 24, 2019

Record last verified: 2019-12