Candida VulvovaginitisPhase 2DOVENCT03253094
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
A Phase 2 study testing Fluconazole and SCY-078 in people with Candida Vulvovaginitis, run by Scynexis, Inc. at 25 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Candida Vulvovaginitis
- What is being tested?
- Fluconazole and SCY-078
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Aug 2017to 4 May 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a female of at least 18 years of age
- Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Who cannot join
- Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
- Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
- Subject is actively menstruating at the time of the Baseline visit.
- Subject has uncontrolled diabetes mellitus.
- Subject has a vaginal sample with pH >4.5.
- Subject has a history of or an active cervical/vaginal cancer.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
UAB Personal Health Clinic
Birmingham, Alabama, 35294
Gulf Coast Research Group, LLC
Brandon, Florida, 33510
Medical Research South, LLC
Charleston, South Carolina, 29407
Clinical Trials Management, LLC
Covington, Louisiana, 70433
Tolan Park Medical Building
Detroit, Michigan, 48201
Unified Women's Clinical Research - Central Carolina
Greensboro, North Carolina, 27408
Tmc Life Research, Inc.
Houston, Texas, 77054
Altus Research, Inc.
Lake Worth, Florida, 33461
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648
OB-GYN Associates of Mid-Florida P.A.
Leesburg, Florida, 34748
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38120
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
New Age Medical Research Corp.
Miami, Florida, 33186
Women Under Study, LLC
New Orleans, Louisiana, 70125
Drexel University
Philadelphia, Pennsylvania, 19102
Precision Trials AZ, LLC
Phoenix, Arizona, 85032
Women's Health Research Center
Plainsboro, New Jersey, 08536
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Atlanta North Gynecology, P.C.
Roswell, Georgia, 30075
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Women's Health Care Research Corp.
San Diego, California, 92111
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105
Visionary Investigators Network
South Miami, Florida, 33160
Consultants in Women's Healthcare, Inc.
St Louis, Missouri, 63131
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).
- Conditions
- Candida Vulvovaginitis
- Being tested
- Fluconazole, SCY-078
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Also called Diflucan, Azole antifungal
Oral Antifungal comparator
SCY-078Drug
Also called Ibrexafungerp
Investigational Antifungal
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Active comparator | 150 mg/day for 1 day Receives: Drug: Fluconazole |
| Ibrexafungerp 750mg | Experimental | 750mg QD for 1 day only Receives: Drug: SCY-078 |
| Ibrexafungerp 300mg | Experimental | 300mg BID for 1 day only Receives: Drug: SCY-078 |
| Ibrexafungerp 450mg | Experimental | 450mg BID for 1 day only Receives: Drug: SCY-078 |
| Ibrexafungerp 150mg | Experimental | 150mg BID for 3 days Receives: Drug: SCY-078 |
| Ibrexafungerp 300mg D1-D3 | Experimental | 300mg BID for 3 days Receives: Drug: SCY-078 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure (Complete Resolution of Signs and Symptoms)
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
Measured: 8-12 days
Secondary outcomes (1)
Co-occurrence of Clinical and Mycological Cure
The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Aug 2017
- Primary completion4 May 2018
- Study completion4 May 2018
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 Candida VulvovaginitisStudies 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
- Model description
- randomized, double-blind, double-dummy, active-controlled, dose-finding
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Angulo, MD, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253094
- Sponsor's protocol ID
- SCY-078-204
- Acronym
- DOVE
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2017
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walley AH, Dupuis LN, Woodahl EL, Killam SR. Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science. Clin Transl Sci. 2025 Sep;18(9):e70362. doi: 10.1111/cts.70362.
PubMed 40970688Nyirjesy P, Schwebke JR, Angulo DA, Harriott IA, Azie NE, Sobel JD. Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis. Clin Infect Dis. 2022 Jul 6;74(12):2129-2135. doi: 10.1093/cid/ciab841.
PubMed 34555149
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT03253094
- Acronym / sponsor ID
- DOVE / SCY-078-204
- Conditions
- Candida Vulvovaginitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- randomized, double-blind, double-dummy, active-controlled, dose-finding
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Active comparator | Drug: Fluconazole150 mg/day for 1 day |
| Ibrexafungerp 750mg | Experimental | Drug: SCY-078750mg QD for 1 day only |
| Ibrexafungerp 300mg | Experimental | Drug: SCY-078300mg BID for 1 day only |
| Ibrexafungerp 450mg | Experimental | Drug: SCY-078450mg BID for 1 day only |
| Ibrexafungerp 150mg | Experimental | Drug: SCY-078150mg BID for 3 days |
| Ibrexafungerp 300mg D1-D3 | Experimental | Drug: SCY-078300mg BID for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is a female of at least 18 years of age
- Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)
Key exclusion criteria (6 listed)
- Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
- Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
- Subject is actively menstruating at the time of the Baseline visit.
- Subject has uncontrolled diabetes mellitus.
- Subject has a vaginal sample with pH >4.5.
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 |
|---|---|---|
| FluconazoleAlso: Diflucan, Azole antifungalOral Antifungal comparator | Drug | Fluconazole |
| SCY-078Also: IbrexafungerpInvestigational Antifungal | Drug | Ibrexafungerp 150mg, Ibrexafungerp 300mg, Ibrexafungerp 300mg D1-D3, Ibrexafungerp 450mg, Ibrexafungerp 750mg |
Primary outcome
Clinical Cure (Complete Resolution of Signs and Symptoms)
Time frame: 8-12 days
Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit
1 secondary outcome
Co-occurrence of Clinical and Mycological Cure
Time frame: 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40970688Walley AH, Dupuis LN, Woodahl EL, Killam SR. Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science. Clin Transl Sci. 2025 Sep;18(9):e70362. doi: 10.1111/cts.70362.
- Derived from this study: PubMed 34555149Nyirjesy P, Schwebke JR, Angulo DA, Harriott IA, Azie NE, Sobel JD. Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis. Clin Infect Dis. 2022 Jul 6;74(12):2129-2135. doi: 10.1093/cid/ciab841.
- Individual participant dataSharing planned: Undecided
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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.
David Angulo, MD study director
Scynexis, Inc.
25 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 Fluconazole and SCY-078 in people with Candida Vulvovaginitis, run by Scynexis, Inc. at 25 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 2 inclusion and 6 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 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 12 Aug 2021). 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?
Clinical Cure (Complete Resolution of Signs and Symptoms) (time frame: 8-12 days). 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 NCT03253094, 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 12 Aug 2021.