Group A for Vulvovaginal Candidiasis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
TMC Life Research, Inc, Houston, TX
Vulvovaginal Candidiasis+2 More
Ibrexafungerp - Drug
Eligibility
18+
Female
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Study Summary

This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.

Eligible Conditions

  • Vulvovaginal Candidiasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 14 Days post Baseline through 60 days post End of Treatment

14 Days post Baseline
Clinical Cure
Day 60
Clinical Improvement
Clinical Success

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ibrexafungerp (SCY-078)
26%Diarrhoea
16%Nausea
9%Headache
7%Abdominal pain
6%Abdominal discomfort
5%Bacterial vaginosis
0%Hypokalaemia
0%Pneumonia and bronchial hyperreactivity
0%Diabetes mellitus
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03734991) in the Ibrexafungerp (SCY-078) ARM group. Side effects include: Diarrhoea with 26%, Nausea with 16%, Headache with 9%, Abdominal pain with 7%, Abdominal discomfort with 6%.

Trial Design

3 Treatment Groups

Group A
1 of 3
Group B (3 Day dosing)
1 of 3
Group b (7 Day dosing)
1 of 3
Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Group A · No Placebo Group · Phase 3

Group A
Drug
Experimental Group · 1 Intervention: Ibrexafungerp · Intervention Types: Drug
Group B (3 Day dosing)
Drug
Experimental Group · 1 Intervention: Ibrexafungerp · Intervention Types: Drug
Group b (7 Day dosing)
Drug
Experimental Group · 1 Intervention: Ibrexafungerp · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrexafungerp
2019
Completed Phase 3
~840

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days post baseline through 60 days post end of treatment
Closest Location: TMC Life Research, Inc · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
2009First Recorded Clinical Trial
1 TrialsResearching Vulvovaginal Candidiasis
3 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe).
You are able to understand and sign a written ICF.
You have at least 2 of the 4 VSS signs or symptoms (moderate or worse) at baseline.
You are a post menarchal female ≥18 years of age at the time of signing the ICF.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.