Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

PHASE3CompletedINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

March 13, 2019

Primary Completion Date

December 2, 2020

Study Completion Date

December 2, 2020

Conditions
Recurrent Vulvovaginal Candidiasis
Interventions
DRUG

Oteseconazole (VT-1161) 150mg capsule

600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14.

DRUG

Fluconazole 150mg capsule

150mg administered every 72 hours in 3 sequential doses starting on Day 1.

DRUG

Placebo

Administered once weekly starting on Day 14.

Trial Locations (33)

28207

37, Charlotte

28304

38, Fayetteville

29572

48, Myrtle Beach

29910

18, Bluffton

31406

17, Savannah

32607

14, Gainesville

33155

36, Miami

33470

33, Loxahatchee Groves

33486

49, Boca Raton

34748

13, Leesburg

37130

21, Murfreesboro

37620

20, Bristol

43213

15, Columbus

46825

41, Fort Wayne

48085

32, Troy

48127

50, Dearborn Heights

48602

29, Saginaw

49686

55, Traverse City

60643

62, Chicago

64111

26, Kansas City

70072

30, Marrero

76104

23, Fort Worth

77450

63, Katy

77573

58, League City

78705

24, Austin

80112

22, Englewood

83404

27, Idaho Falls

83687

10, Nampa

85712

34, Tucson

90036

25, Los Angeles

91436

39, Encino

08901

42, New Brunswick

07712

47, Ocean City

Sponsors
All Listed Sponsors
lead

Mycovia Pharmaceuticals Inc.

INDUSTRY