Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

Completed · Phase 3 · Has a placebo group

Conditions studied: Candida Vulvovaginitis

In brief

This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.

Key facts

Study ID

NCT03734991

Run by

Scynexis, Inc.

People needed

376

Starts

2019-01-04

Expected to finish

2019-09-04

Last updated by the study team

2021-09-08

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is a postmenarchal female subject 12 years and older
• 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)

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Precision Trials AZ, LLC — Phoenix, Arizona, United States
• Womens' Health Care Research Corp — San Diego, California, United States
• Women's Medical Research Group — Clearwater, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• OBGYN Assoc of Mid Florida — Leesburg, Florida, United States
• New Age Medical Research Corporation — Miami, Florida, United States
• Clinical Trials Management LLC — Covington, Louisiana, United States
• Clinical Trials Management LLC — Metairie, Louisiana, United States
• Unified Women's Clinical Research- Hagerstown — Hagerstown, Maryland, United States
• Wayne State University — Detroit, Michigan, United States
• Consultants In Women's Healthcare, Inc. — St Louis, Missouri, United States
• Center For Women's Health and Wellness LLC - Interspond - PPDS — Lawrenceville, New Jersey, United States
• Lawrence OB/GYN Clinical Research, LLC — Lawrenceville, New Jersey, United States
• GYN Center for Women PA — Durham, North Carolina, United States
• Carolina Women's Research and Wellness Center — Durham, North Carolina, United States
• Unified Women's Clinical Research Greensboro — Greensboro, North Carolina, United States
• Unified Women's Clinical Research — Morehead City, North Carolina, United States
• Unified Women's Clinical Research Raleigh — Raleigh, North Carolina, United States
• Unified Women's Clinical Research - Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Medical Research South — Charleston, South Carolina, United States
• Magnolia Ob/Gyn Research Center, LLC — Myrtle Beach, South Carolina, United States
• Medical Research Center of Memphis — Memphis, Tennessee, United States
• TMC Life Research Inc — Houston, Texas, United States
• Group For Women — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.