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

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

NCT03987620

Run by

Scynexis, Inc.

People needed

455

Starts

2019-06-07

Expected to finish

2020-04-29

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% Potassium Hydroxide (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) anti fungal treatment, including prescription or over-the-counter products during the study and treatment for vulvovaginal candidiasis (VVC) 28 days prior to randomization.
• 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

• Mesa OB-GYN — Mesa, Arizona, United States
• Red Rocks OBGYN — Lakewood, Colorado, United States
• Planned Parenthood Southern New England — New Haven, Connecticut, United States
• New Generation Medical Research — Hialeah, Florida, United States
• Healthcare Clinical Data Inc — North Miami, Florida, United States
• Physician Care Clinical Research LLC — Sarasota, Florida, United States
• CCT LLC - A VitaLink Company- PPDS — West Palm Beach, Florida, United States
• Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• Fellows Research Alliance Inc — Savannah, Georgia, United States
• Rosemark Women Care Specialists — Idaho Falls, Idaho, United States
• Praetorian Pharmaceutical Research, LLC — Marrero, Louisiana, United States
• North County Health Center, Planned Parenthood of the St. Louis Region and Southwest Missouri — Florissant, Missouri, United States
• Clinical Research Center Of Nevada — Las Vegas, Nevada, United States
• Planned Parenthood North Central Southern New Jersey (PPNCSNJ) — Hackensack, New Jersey, United States
• Carolina Institute for Clinical Research - M3 Wake Research — Fayetteville, North Carolina, United States
• Obstetrics and Gynecology Associates of Erie, PC — Erie, Pennsylvania, United States
• Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center — Philadelphia, Pennsylvania, United States
• Fellows Research Alliance Inc — Bluffton, South Carolina, United States
• Chattanooga Medical Research Inc — Chattanooga, Tennessee, United States
• Signature GYN Services, PLLC — Fort Worth, Texas, United States
• Brownstone Clinical Trials, LLC — Irving, Texas, United States
• Multiprofile Hospital for Active Treatment -Asenovgrad EOOD — Asenovgrad, Bulgaria
• MHAT Puls AD - PPDS — Blagoevgrad, Bulgaria
• Multiprofile Hospital for Active Treatment - Chirpan EOOD — Chirpan, Bulgaria
• Medical Center Asklepii OOD — Dupnitsa, Bulgaria

Full record on ClinicalTrials.gov

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