Clinical Trial: A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Acute Vaginal Candidiasis (Yeast Infection)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2a, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute

Brief Summary: CYP51 is an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of compounds toxic to the fungus. CYP51 is the target of the class of drugs referred to as 'azole antifungals'. The lack of selectivity by the azole antifungals is responsible for many of the side effects associated with these drugs. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis)

Detailed Summary:
Sponsor: Viamet

Current Primary Outcome:

• To evaluate the composite clinical efficacy of oral VT-1161 compared with fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: Test of Cure conducted at baseline (day 1) ]
  Vulvovaginal signs and symptoms will be evaluated at screening/baseline and at test of cure day 28 (Week 4)
• To evaluate the composite clinical efficacy of oral VT-1161 compared with oral fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: 4 weeks ]
  Clinical efficacy will be evaluated at screening/baseline (Day 1) and at test-of-cure visit Week 4 (Day 28)

Original Primary Outcome:

• To evaluate the composite clinical efficacy of VT-1161 compared with fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: Test of Cure conducted at baseline (day 1) ]
  Vulvovaginal signs and symptoms will be evaluated at screening/baseline and at test of cure day 28 (Week 4)
• To evaluate the composite clinical efficacy of VT-1161 compared with fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: 4 weeks ]
  Clinical efficacy will be evaluated at screening/baseline (Day 1) and at test-of-cure visit Week 4 (Day 28)

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Viamet

Dates:
Date Received: June 17, 2013
Date Started: August 2013
Date Completion:
Last Updated: December 22, 2014
Last Verified: March 2014