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NCT04029116 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

A Phase 3 study, sponsored by Scynexis.

Completed
Registry status
Phase 3
Development phase
440
Enrollment target

NCT04029116: Completed Phase 3 study, sponsored by Scynexis.

NCT04029116 is a Phase 3 study that has completed, run by Scynexis. The registered enrollment target is 440 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04029116, a Phase 3 study, has completed, sponsored by Scynexis.

COMPLETED
Registry status
Phase 3
Development phase
440 participants
Enrollment target

Study Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

Primary Outcome

Efficacy as measured by the percentage of subjects with documented Clinical Success.

Interventions

  • DRUG Placebo oral tablet
  • DRUG Fluconazole Tablet
  • DRUG IBREXAFUNGERP

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2019-10-21
Est. Completion 2021-11-29
Phase Phase 3
Scynexis

13 total trials

What the finished NCT04029116 record still lists

NCT04029116 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.

NCT04029116 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04029116 about?

NCT04029116 is a clinical study titled "Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)". This study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral ibrexafungerp (formerly "SCY-078") compared to placebo in female subjects 12 years and older with recurrent VVC (RVVC).

What is the current status of trial NCT04029116?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2019-10-21. Estimated completion is 2021-11-29.

What interventions are being tested in trial NCT04029116?

The interventions under investigation include: Placebo oral tablet (DRUG), Fluconazole Tablet (DRUG), IBREXAFUNGERP (DRUG).

Who is sponsoring clinical trial NCT04029116?

This trial is sponsored by Scynexis, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04029116's enrollment target sits among peer trials

440 867th of 2000 higher than 1,129 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04029116, the US trial registry maintained by the National Library of Medicine. NCT04029116 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.