Recurrent Vulvovaginal CandidiasisPhase 2NCT02267382
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
A Phase 2 study testing VT-1161 in people with Recurrent Vulvovaginal Candidiasis, run by Viamet at 32 sites in United States.
Trial summary
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- VT-1161
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 32 sitesUnited States
- Study dates
- 10 Feb 2015to 9 Nov 2016
- 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
- Clinical diagnosis of symptomatic acute VVC
- 3 or more episodes of acute VVC in the past 12 months
- Positive KOH
- Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening
- Composite vulvovaginal signs and symptoms score of <3 at Baseline
- Must be able to swallow tablets
Who cannot join
- Evidence of major organ system disease
- Presence or a history of another vaginal or vulvar condition(s)
- History of cervical cancer
- Poorly controlled diabetes mellitus
- Pregnant
- Recent use of topical or systemic antifungal drugs
- Recent use of immunosuppressive or system corticosteroid therapies
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Radiant Research
Akron, Ohio, 44311
University of Alabama Birmingham
Birmingham, Alabama, 35233
Clinical Trials Management LLC
Covington, Louisiana, 70471
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Brownstone Clinical Trials
Fort Worth, Texas, 76104
TMC Life Research
Houston, Texas, 77054
Brownstone Clinical Trials
Irving, Texas, 75062
NEA Baptist Clinic
Jonesboro, Arkansas, 72401
Altus Research
Lake Worth, Florida, 33461
Clinical Research of Nevada
Las Vegas, Nevada, 89123
R. Garn Mabey, Jr. M.D. Chartered
Las Vegas, Nevada, 89128
OB/GYN Clinical Research
Lawrenceville, New Jersey, 08648
Axis Clinical Trials
Los Angeles, California, 90017
Axis Clinical Trials
Los Angeles, California, 90036
Clinical Trials Management LLC
Metairie, Louisiana, 70006
Healthcare Clinical Data
Miami, Florida, 33161
Community Medical Research
North Miami, Florida, 33181
Vision Clinical Research
Palm Beach, Florida, 33414
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Precision Trials
Phoenix, Arizona, 85032
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Women's Health Research Center
Plainsboro, New Jersey, 08536
Suffolk OB-GYN
Port Jefferson, New York, 11777
United Women's Clinical Research-Raleigh
Raleigh, North Carolina, 27607
Clinical Trials of Texas
San Antonio, Texas, 78229
Genesis Center for Clinical Research
San Diego, California, 92103
Physician's Research Options LLC
Sandy City, Utah, 84020
Physician Care Clinical Research LLC
Sarasota, Florida, 34239
Seattle Women's Health Research Gynecology
Seattle, Washington, 98105
Clinical Research of West Florida
Tampa, Florida, 33603
Cypress Medical Research Center
Wichita, Kansas, 67226
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Being tested
- VT-1161, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| VT-1161 Low-dose 3-month | Experimental | 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks Receives: Drug: VT-1161 |
| VT-1161 Low-dose 6-month | Experimental | 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks Receives: Drug: VT-1161 |
| VT-1161 High-dose 3-month | Experimental | 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks Receives: Drug: VT-1161 |
| VT-1161 High-dose 24-week | Experimental | 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks Receives: Drug: VT-1161 |
| Placebo | Placebo comparator | 2 placebo tablets once daily for 7 days, then once weekly for 23 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome.
0 = none (complete absence of any sign or symptom)
- = mild (slight)
- = moderate (definitely present)
- = severe (marked, intense)
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start10 Feb 2015
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
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 Recurrent 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viamet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267382
- Sponsor's protocol ID
- VMT-VT-1161-CL-006
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2014
- Last updated
- 15 Oct 2019
- 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, Degenhardt TP, Person K, Sobel JD, Nyirjesy P, Schotzinger RJ, Tavakkol A. A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of orally administered VT-1161 in the treatment of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol. 2018 Jun;218(6):624.e1-624.e9. doi: 10.1016/j.ajog.2018.03.001. Epub 2018 Mar 11.
PubMed 29534874
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT02267382
- Acronym / sponsor ID
- VMT-VT-1161-CL-006
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- ViametIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2015 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VT-1161 Low-dose 3-month | Experimental | Drug: VT-11611 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks |
| VT-1161 Low-dose 6-month | Experimental | Drug: VT-11611 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks |
| VT-1161 High-dose 3-month | Experimental | Drug: VT-11612 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks |
| VT-1161 High-dose 24-week | Experimental | Drug: VT-11612 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks |
| Placebo | Placebo comparator | Drug: Placebo2 placebo tablets once daily for 7 days, then once weekly for 23 weeks |
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)
- Clinical diagnosis of symptomatic acute VVC
- 3 or more episodes of acute VVC in the past 12 months
- Positive KOH
- Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening
- Composite vulvovaginal signs and symptoms score of <3 at Baseline
Key exclusion criteria (7 listed)
- Evidence of major organ system disease
- Presence or a history of another vaginal or vulvar condition(s)
- History of cervical cancer
- Poorly controlled diabetes mellitus
- Pregnant
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 High-dose 24-week, VT-1161 High-dose 3-month, VT-1161 Low-dose 3-month, VT-1161 Low-dose 6-month |
| Placebo | Drug | Placebo |
Primary outcome
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
Time frame: 48 Weeks
A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- 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 29534874Brand SR, Degenhardt TP, Person K, Sobel JD, Nyirjesy P, Schotzinger RJ, Tavakkol A. A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of orally administered VT-1161 in the treatment of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol. 2018 Jun;218(6):624.e1-624.e9. doi: 10.1016/j.ajog.2018.03.001. Epub 2018 Mar 11.
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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.
32 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 in people with Recurrent Vulvovaginal Candidiasis, run by Viamet at 32 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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. Some participants in this study may receive a placebo. 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 4 Oct 2019). 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?
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. (time frame: 48 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 NCT02267382, 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 15 Oct 2019.