Vulvovaginal CandidiasisNCT04208555
Comparison of Boric Acid vs. Terconazole in Treatment of RVVC
A study testing Boric Acid Vaginal Suppository and Terconazole Vaginal Suppository in people with Vulvovaginal Candidiasis, run by Hatem AbuHashim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Boric Acid Vaginal Suppository and Terconazole Vaginal Suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Comparison of Boric Acid Versus Terconazole in Treatment of Recurrent Vulvovaginal Candidiasis
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
- Being tested
- Boric Acid Vaginal Suppository, Terconazole Vaginal Suppository
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boric Acid Vaginal SuppositoryDrug
Boric acid vaginal suppository (600 mg/day) for 14 days
Terconazole Vaginal SuppositoryDrug
Terconazole 80 mg vaginal suppository daily for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Boric acid vaginal suppository | Experimental | Not described Receives: Drug: Boric Acid Vaginal Suppository |
| Terconazole vaginal suppository | Active comparator | Not described Receives: Drug: Terconazole Vaginal Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure rate
Negative Candida by cultures of high vaginal swabs
Measured: At day 15 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Jan 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatem AbuHashim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem AbuHashim, Mansoura University
- Investigators
- Hatem Abu Hashim, MD. FRCOG. PhD, Study chair, Faculty of Medicine, Mansoura UniversityAsmaa Swidan, MBBCh, Principal investigator, New Mansoura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208555
- Sponsor's protocol ID
- MS.19.09.825
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21774671
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Boric Acid Versus Terconazole in Treatment of Recurrent Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT04208555
- Acronym / sponsor ID
- MS.19.09.825
- Conditions
- Vulvovaginal Candidiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hatem AbuHashimUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boric acid vaginal suppository | Experimental | Drug: Boric Acid Vaginal Suppository |
| Terconazole vaginal suppository | Active comparator | Drug: Terconazole Vaginal Suppository |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boric Acid Vaginal SuppositoryBoric acid vaginal suppository (600 mg/day) for 14 days | Drug | Boric acid vaginal suppository |
| Terconazole Vaginal SuppositoryTerconazole 80 mg vaginal suppository daily for 6 days | Drug | Terconazole vaginal suppository |
Primary outcome
Mycological cure rate
Time frame: At day 15 of treatment
Negative Candida by cultures of high vaginal swabs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Background: PubMed 21774671Iavazzo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatem Abu Hashim, MD. FRCOG. PhD study chair
Faculty of Medicine, Mansoura University
Asmaa Swidan, MBBCh principal investigator
New Mansoura General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Boric Acid Vaginal Suppository and Terconazole Vaginal Suppository in people with Vulvovaginal Candidiasis, run by Hatem AbuHashim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hatem Abu Hashim, MD.FRCOG.PhD (+20502300002, hatem_ah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological cure rate (time frame: At day 15 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.