Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection) (NCT NCT01891331)
NCT ID: NCT01891331
Last Updated: 2018-08-01
Results Overview
For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: 1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; 2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; 3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
4 weeks
Results posted on
2018-08-01
Participant Flow
Participant milestones
| Measure |
VT-1161 300mg QD
VT-1161 300mg once daily for 3 days
|
VT-1161 600mg QD
VT-1161 600mg once daily for 3 days
|
VT-1161 600mg BID
VT-1161 600mg twice daily for 3 days
|
Fluconazole 150mg
Single dose of fluconazole 150mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
14
|
15
|
|
Overall Study
COMPLETED
|
12
|
10
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
Baseline characteristics by cohort
| Measure |
VT-1161 300mg QD
n=14 Participants
|
VT-1161 600mg QD
n=12 Participants
|
VT-1161 600mg BID
n=14 Participants
|
Fluconazole 150mg
n=15 Participants
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 12.01 • n=93 Participants
|
38.2 years
STANDARD_DEVIATION 11.77 • n=4 Participants
|
27.6 years
STANDARD_DEVIATION 7.37 • n=27 Participants
|
31.3 years
STANDARD_DEVIATION 8.22 • n=483 Participants
|
32.7 years
STANDARD_DEVIATION 10.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
55 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 4 weeksFor this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: 1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; 2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; 3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
Outcome measures
| Measure |
VT-1161 300mg QD
n=14 Participants
|
VT-1161 600mg QD
n=12 Participants
|
VT-1161 600mg BID
n=14 Participants
|
Fluconazole 150mg
n=15 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
|
9 Participants
|
9 Participants
|
11 Participants
|
10 Participants
|
Adverse Events
VT-1161 300mg QD
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
VT-1161 600mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VT-1161 600mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fluconazole 150mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VT-1161 300mg QD
n=14 participants at risk
|
VT-1161 600mg QD
n=12 participants at risk
|
VT-1161 600mg BID
n=14 participants at risk
|
Fluconazole 150mg
n=15 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14
|
16.7%
2/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Conjunctivitis Bacterial
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Ear Infection
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Infections and infestations
Influenza
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
13.3%
2/15
|
|
Infections and infestations
Esophageal Candidiasis
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/15
|
|
Infections and infestations
Sinusitits
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Trichamoniasis
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
1/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
1/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Infections and infestations
Vaginitis Bacterial
|
14.3%
2/14
|
8.3%
1/12
|
0.00%
0/14
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Nervous system disorders
Headache
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
13.3%
2/15
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Renal and urinary disorders
Urine Odor Abnormal
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Reproductive system and breast disorders
Dyspareunia
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Metrorrhagia
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Uterine Hemorrhage
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.00%
0/14
|
8.3%
1/12
|
7.1%
1/14
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/15
|
|
Vascular disorders
Hematoma
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither institution nor principal investigator shall publish the results of the trial without prior written consent of the sponsor, which it may withhold in its sole discretion.
- Publication restrictions are in place
Restriction type: OTHER