Candidiasis, VulvovaginalPhase 2NCT01891331
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
A Phase 2 study testing VT-1161 and Fluconazole in people with Candidiasis, Vulvovaginal, run by Viamet at 8 sites in United States.
Trial summary
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- VT-1161 and Fluconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ≥18 and <65 years
- Clinical diagnosis of symptomatic acute VVC
- Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
- At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
- A minimum composite vulvovaginal signs and symptoms score of ≥6
- must be be able to swallow capsules
Who cannot join
- Evidence of major organ system disease
- History of cervical cancer
- History of diabetes mellitus
- Pregnant
- Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
- Recent use of drugs to treat vaginal infections
- Recent use of immunosuppressive therapies
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Brownstone Clinical Trials, LLC
Irving, Texas, 75062
Altus Research
Lake Worth, Florida, 33461
Healthcare Clinical Data, Inc
North Miami, Florida, 33161
Drexel Vaginitis Center
Philadelphia, Pennsylvania, 19102
Lyndhurst Clinical Research
Raleigh, North Carolina, 27607
Harborview ID Research Clinic
Seattle, Washington, 98104
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- VT-1161, Fluconazole
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-1161Drug
FluconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| VT-1161 300mg QD | Experimental | Not described Receives: Drug: VT-1161 |
| VT-1161 600mg QD | Experimental | Not described Receives: Drug: VT-1161 |
| VT-1161 600mg BID | Experimental | Not described Receives: Drug: VT-1161 |
| Fluconazole 150mg | Active comparator | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following:
- complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;
- any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;
- no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, VulvovaginalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viamet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891331
- Sponsor's protocol ID
- VMT-VT-1161-CL-004
- Status last verified
- Jul 2018
- First submitted
- 17 Jun 2013
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.
PubMed 36396498Brand SR, Sobel JD, Nyirjesy P, Ghannoum MA, Schotzinger RJ, Degenhardt TP. A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis. Clin Infect Dis. 2021 Oct 5;73(7):e1518-e1524. doi: 10.1093/cid/ciaa1204.
PubMed 32818963
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT01891331
- Acronym / sponsor ID
- VMT-VT-1161-CL-004
- Conditions
- Candidiasis, Vulvovaginal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- ViametIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Posted 6 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VT-1161 300mg QD | Experimental | Drug: VT-1161 |
| VT-1161 600mg QD | Experimental | Drug: VT-1161 |
| VT-1161 600mg BID | Experimental | Drug: VT-1161 |
| Fluconazole 150mg | Active comparator | Drug: Fluconazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females ≥18 and <65 years
- Clinical diagnosis of symptomatic acute VVC
- Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
- At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
- A minimum composite vulvovaginal signs and symptoms score of ≥6
Key exclusion criteria (7 listed)
- Evidence of major organ system disease
- History of cervical cancer
- History of diabetes mellitus
- Pregnant
- Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
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 |
|---|---|---|
| VT-1161 | Drug | VT-1161 300mg QD, VT-1161 600mg BID, VT-1161 600mg QD |
| Fluconazole | Drug | Fluconazole 150mg |
Primary outcome
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
Time frame: 4 weeks
For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: 1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; 2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; 3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36396498Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.
- Derived from this study: PubMed 32818963Brand SR, Sobel JD, Nyirjesy P, Ghannoum MA, Schotzinger RJ, Degenhardt TP. A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis. Clin Infect Dis. 2021 Oct 5;73(7):e1518-e1524. doi: 10.1093/cid/ciaa1204.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VT-1161 and Fluconazole in people with Candidiasis, Vulvovaginal, run by Viamet at 8 sites in United States.
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: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population (time frame: 4 weeks). 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 NCT01891331, which also lists 2 linked publications.
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 1 Aug 2018.