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A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)

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ClinicalTrials.gov Identifier: NCT01891331
Recruitment Status : Completed
First Posted : July 3, 2013
Results First Posted : July 6, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Viamet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Candidiasis, Vulvovaginal
Interventions Drug: VT-1161
Drug: Fluconazole
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg
Hide Arm/Group Description VT-1161 300mg once daily for 3 days VT-1161 600mg once daily for 3 days VT-1161 600mg twice daily for 3 days Single dose of fluconazole 150mg
Period Title: Overall Study
Started 14 12 14 15
Completed 12 10 13 13
Not Completed 2 2 1 2
Arm/Group Title VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 14 12 14 15 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 14 participants 15 participants 55 participants
34.4  (12.01) 38.2  (11.77) 27.6  (7.37) 31.3  (8.22) 32.7  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 14 participants 15 participants 55 participants
Female
14
 100.0%
12
 100.0%
14
 100.0%
15
 100.0%
55
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
Hide Description

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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 14 12 14 15
Measure Type: Count of Participants
Unit of Measure: Participants
9
  64.3%
9
  75.0%
11
  78.6%
10
  66.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/12 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VT-1161 300mg QD VT-1161 600mg QD VT-1161 600mg BID Fluconazole 150mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/14 (71.43%)   6/12 (50.00%)   3/14 (21.43%)   10/15 (66.67%) 
Cardiac disorders         
Palpitations  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Eye disorders         
Conjunctivitis  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders         
Abdominal Pain  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Nausea  1/14 (7.14%)  2/12 (16.67%)  0/14 (0.00%)  0/15 (0.00%) 
Infections and infestations         
Conjunctivitis Bacterial  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Ear Infection  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Herpes Simplex  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Influenza  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Nasopharyngitis  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  2/15 (13.33%) 
Esophageal Candidiasis  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Pharyngitis  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Sinusitits  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Trichamoniasis  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Upper Respiratory Tract Infection  1/14 (7.14%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Urinary Tract Infection  1/14 (7.14%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Vaginitis Bacterial  2/14 (14.29%)  1/12 (8.33%)  0/14 (0.00%)  2/15 (13.33%) 
Injury, poisoning and procedural complications         
Laceration  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Investigations         
Liver Function Test Abnormal  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back Pain  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Pain in Extremity  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Nervous system disorders         
Carpal Tunnel Syndrome  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Dizziness  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Dysgeusia  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Headache  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Pregnancy  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  2/15 (13.33%) 
Psychiatric disorders         
Insomnia  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders         
Urine Odor Abnormal  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Reproductive system and breast disorders         
Dysmenorrhea  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Dyspareunia  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Fibrocystic Breast Disease  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%)  0/15 (0.00%) 
Metrorrhagia  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Uterine Hemorrhage  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Vaginal Discharge  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Vulvovaginal Pruritus  0/14 (0.00%)  1/12 (8.33%)  1/14 (7.14%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal Pain  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis Contact  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Erythema  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%)  0/15 (0.00%) 
Pruritus  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
Urticaria  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%)  0/15 (0.00%) 
Vascular disorders         
Hematoma  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%)  1/15 (6.67%) 
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 principal investigator shall publish the results of the trial without prior written consent of the sponsor, which it may withhold in its sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neil Moore
Organization: Viamet Pharmaceuticals Inc
EMail: nmoore@viamet.com
Layout table for additonal information
Responsible Party: Viamet
ClinicalTrials.gov Identifier: NCT01891331     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-004
First Submitted: June 17, 2013
First Posted: July 3, 2013
Results First Submitted: June 6, 2018
Results First Posted: July 6, 2018
Last Update Posted: August 1, 2018