Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

PHASE3CompletedINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

October 21, 2019

Primary Completion Date

September 1, 2021

Study Completion Date

November 29, 2021

Conditions
Recurrent Vulvovaginal Candidiasis
Interventions
DRUG

Fluconazole Tablet

150 mg every 72 hours for 3 doses

DRUG

IBREXAFUNGERP

300 mg BID (one day) every 4 weeks for a total of 6 dosing days

DRUG

Placebo oral tablet

BID (one day) every 4 weeks for a total of 6 dosing days

Trial Locations (25)

16507

Obstetrics and Gynecology Associates of Erie, PC, Erie

19107

Jefferson University Hospital, Philadelphia

21740

Unified Women's Clinical Research, Hagerstown

27103

Group For Women, Winston-Salem

Lyndhurst Clinical Research, Winston-Salem

27408

Unified Womens CLinical Research, Greensboro

27607

Unified Women's Clinical Research Raleigh, Raleigh

27612

M3 Wake Research, Inc, Raleigh

27713

Carolina Women's Research and Wellness Center, Durham

33161

Healthcare Clinical Data Inc, North Miami

33186

New Age Medical Research Corporation, Miami

33461

Altus Research - Hunt - PPDS, Lake Worth

37404

Chattanooga Medical Research Inc, Chattanooga

38120

Medical Research Center of Memphis, LLC, Memphis

44195

Cleveland Clinic, Cleveland

48201

Wayne State University, Detroit

70125

Women Under Study, LLC, New Orleans

70433

Clinical Trials Management, Covington

77054

TMC Life Research Inc, Houston

83404

Clinical Research Prime - ClinEdge - PPDS, Idaho Falls

85032

Precision Trials LLC, Phoenix

87109

Bosque Women's Care, Albuquerque

92111

Women's Healthcare Research Corp, San Diego

08648

Center For Women's Health and Wellness LLC, Lawrenceville

Lawrence Obstetrics Gynecology Clinical Research LLC, Lawrenceville

All Listed Sponsors
lead

Scynexis, Inc.

INDUSTRY

NCT04029116 - Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) | Biotech Hunter | Biotech Hunter