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

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ClinicalTrials.gov Identifier: NCT03840616
Recruitment Status : Completed
First Posted : February 15, 2019
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Mycovia Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Recurrent Vulvovaginal Candidiasis
Interventions Drug: Oteseconazole (VT-1161) 150mg capsule
Drug: Fluconazole 150mg capsule
Drug: Placebo
Enrollment 219
Recruitment Details After providing consent, 251 subjects were screened and, of those, a total of 219 subjects were randomly assigned to the oteseconazole or fluconazole/placebo group for a 2-week induction phase. During the induction phase, subjects received either oteseconazole or fluconazole. Subjects whose presenting acute VVC episode resolved during the induction phase (a total of 185 subjects) entered a 48-week maintenance phase comprised of an 11-week treatment period and a 37-week follow-up period.
Pre-assignment Details Of the 251 subjects screened, 32 did not meet eligibility requirements and were not enrolled (i.e., not assigned to a treatment arm for the 2-week induction phase).
Arm/Group Title Oteseconazole (VT-1161) Fluconazole / Placebo
Hide Arm/Group Description 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
Period Title: 2-Week Induction Phase
Started 147 72
Completed 123 62
Not Completed 24 10
Period Title: 48-Week Maintenance Phase
Started 123 62
Completed 112 55
Not Completed 11 7
Arm/Group Title Oteseconazole (VT-1161) Fluconazole / Placebo Total
Hide Arm/Group Description 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14. Total of all reporting groups
Overall Number of Baseline Participants 147 72 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 72 participants 219 participants
34  (10.7) 36  (11.7) 35  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 72 participants 219 participants
Female
147
 100.0%
72
 100.0%
219
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 72 participants 219 participants
American Indian or Alaska Native
1
   0.7%
1
   1.4%
2
   0.9%
Asian
3
   2.0%
0
   0.0%
3
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
47
  32.0%
27
  37.5%
74
  33.8%
White
88
  59.9%
42
  58.3%
130
  59.4%
More than one race
7
   4.8%
2
   2.8%
9
   4.1%
Unknown or Not Reported
1
   0.7%
0
   0.0%
1
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants 72 participants 219 participants
147 72 219
1.Primary Outcome
Title Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population
Hide Description

The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome.

0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)

Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation.
Arm/Group Title Oteseconazole (VT-1161) Fluconazole / Placebo
Hide Arm/Group Description:
600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14.
150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14.
Overall Number of Participants Analyzed 147 72
Measure Type: Number
Unit of Measure: percentage of participants
5.1 42.2
Time Frame Day 1 through Week 50
Adverse Event Reporting Description The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
 
Arm/Group Title Oteseconazole (Induction Phase) Oteseconazole (Maintenance Phase) Fluconazole (Induction Phase) Placebo (Maintenance Phase)
Hide Arm/Group Description 600mg oteseconazole on Day 1 and 450mg oteseconazole on Day 2 150mg oteseconazole once weekly for 11 weeks starting on Day 14. 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1 Placebo once weekly for 11 weeks starting on Day 14.
All-Cause Mortality
Oteseconazole (Induction Phase) Oteseconazole (Maintenance Phase) Fluconazole (Induction Phase) Placebo (Maintenance Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)      1/123 (0.81%)      0/72 (0.00%)      0/62 (0.00%)    
Hide Serious Adverse Events
Oteseconazole (Induction Phase) Oteseconazole (Maintenance Phase) Fluconazole (Induction Phase) Placebo (Maintenance Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/146 (0.00%)      3/123 (2.44%)      0/72 (0.00%)      1/62 (1.61%)    
Blood and lymphatic system disorders         
Anaemia   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Gastrointestinal disorders         
Retroperitoneal haemorrhage   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Infections and infestations         
Appendicitis   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Pneumonia   0/146 (0.00%)  0 0/123 (0.00%)  0 0/72 (0.00%)  0 1/62 (1.61%)  1
Pneumonia viral   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Pulmonary embolism   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Vascular disorders         
Deep vein thrombosis   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 0/62 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Oteseconazole (Induction Phase) Oteseconazole (Maintenance Phase) Fluconazole (Induction Phase) Placebo (Maintenance Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/146 (5.48%)      35/123 (28.46%)      8/72 (11.11%)      21/62 (33.87%)    
Gastrointestinal disorders         
Nausea   3/146 (2.05%)  3 4/123 (3.25%)  5 0/72 (0.00%)  0 2/62 (3.23%)  2
Diarrhoea   0/146 (0.00%)  0 1/123 (0.81%)  1 1/72 (1.39%)  1 3/62 (4.84%)  3
Vomiting   0/146 (0.00%)  0 2/123 (1.63%)  2 0/72 (0.00%)  0 2/62 (3.23%)  2
General disorders         
Pyrexia   1/146 (0.68%)  1 6/123 (4.88%)  7 0/72 (0.00%)  0 3/62 (4.84%)  5
Fatigue   0/146 (0.00%)  0 4/123 (3.25%)  4 0/72 (0.00%)  0 1/62 (1.61%)  1
Infections and infestations         
Urinary tract infection   1/146 (0.68%)  1 17/123 (13.82%)  21 3/72 (4.17%)  3 11/62 (17.74%)  11
Bacterial vaginosis   1/146 (0.68%)  1 16/123 (13.01%)  24 2/72 (2.78%)  2 9/62 (14.52%)  15
Upper respiratory tract infection   0/146 (0.00%)  0 7/123 (5.69%)  8 1/72 (1.39%)  1 1/62 (1.61%)  1
Influenza   0/146 (0.00%)  0 3/123 (2.44%)  3 0/72 (0.00%)  0 3/62 (4.84%)  3
Fungal infection   0/146 (0.00%)  0 2/123 (1.63%)  3 1/72 (1.39%)  1 2/62 (3.23%)  4
Sinusitis   1/146 (0.68%)  1 1/123 (0.81%)  1 0/72 (0.00%)  0 3/62 (4.84%)  4
Nasopharyngitis   0/146 (0.00%)  0 3/123 (2.44%)  3 0/72 (0.00%)  0 1/62 (1.61%)  1
Pharyngitis streptococcal   0/146 (0.00%)  0 3/123 (2.44%)  3 0/72 (0.00%)  0 1/62 (1.61%)  1
Bronchitis   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 2/62 (3.23%)  2
Corona virus infection   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 2/62 (3.23%)  2
Vulvovaginal candidiasis   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 2/62 (3.23%)  2
Lower respiratory tract infection   0/146 (0.00%)  0 0/123 (0.00%)  0 0/72 (0.00%)  0 2/62 (3.23%)  2
Injury, poisoning and procedural complications         
Ligament sprain   0/146 (0.00%)  0 0/123 (0.00%)  0 0/72 (0.00%)  0 2/62 (3.23%)  3
Musculoskeletal and connective tissue disorders         
Musculoskeletal chest pain   0/146 (0.00%)  0 0/123 (0.00%)  0 0/72 (0.00%)  0 2/62 (3.23%)  2
Nervous system disorders         
Headache   3/146 (2.05%)  4 5/123 (4.07%)  5 2/72 (2.78%)  2 4/62 (6.45%)  10
Reproductive system and breast disorders         
Vulvovaginal pruritus   0/146 (0.00%)  0 1/123 (0.81%)  1 0/72 (0.00%)  0 3/62 (4.84%)  3
Respiratory, thoracic and mediastinal disorders         
Cough   0/146 (0.00%)  0 0/123 (0.00%)  0 1/72 (1.39%)  1 2/62 (3.23%)  2
Skin and subcutaneous tissue disorders         
Rash   1/146 (0.68%)  1 3/123 (2.44%)  3 0/72 (0.00%)  0 1/62 (1.61%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Neither institution nor investigator can disclose information pertaining to study until sponsor issues multi-center publication. If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Administration
Organization: Mycovia Pharmaceuticals Inc
Phone: 919-467-8539
EMail: adminops@mycovia.com
Layout table for additonal information
Responsible Party: Mycovia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03840616    
Other Study ID Numbers: VMT-VT-1161-CL-017
First Submitted: February 11, 2019
First Posted: February 15, 2019
Results First Submitted: November 29, 2021
Results First Posted: February 4, 2022
Last Update Posted: February 4, 2022