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Albaconazole

Clinical trials are investigating Albaconazole in women with acute Candida vulvovaginitis, also called acute vulvovaginal candidiasis. The studies aim to evaluate how well it works, how safe it is, and how the body handles it. They also compare Albaconazole with fluconazole and placebo.

Table of Contents

Trial overview

The available study of Albaconazole was designed to assess its efficacy, safety, and pharmacokinetics in acute Candida vulvovaginitis.[1] Acute Candida vulvovaginitis is also called acute vulvovaginal candidiasis, which is a yeast infection affecting the vulva and vagina.[1]

This was a Phase 2 study, which means it was a mid-stage clinical trial focused on learning more about whether the treatment works while still monitoring safety.[1]

Study design and treatment groups

The trial was described as double-blind and randomised, meaning treatment groups were assigned by chance and neither the participants nor the study team knew who received which treatment during the study.[1]

It was also a dose-finding trial, so the study aimed to assess different Albaconazole doses, listed as XX, YY, and ZZ in the source data, against comparison groups.[1]

The study compared Albaconazole with fluconazole and placebo, and the source also lists placebo groups for both Albaconazole and fluconazole.[1] A placebo is a look-alike treatment with no active medicine, used to help show whether the study drug has an effect beyond no active treatment.[1]

Who could participate

The trial focused on subjects with acute vulvovaginal candidiasis.[1] The source data do not provide more detailed inclusion or exclusion criteria, so the exact participation rules are not listed here.

The brief summary says the study was designed for subjects with acute Candida vulvovaginitis, which points to women with an active yeast infection in the vaginal area.[1]

What was measured

The main outcome was the percentage of subjects with clinical cure at the Final Visit.[1] In this trial, clinical cure was defined as a vulvovaginal score sum of 0, meaning no measured signs or symptoms remained at that visit.[1]

The study also aimed to assess safety and pharmacokinetics.[1] Pharmacokinetics means how the body absorbs, moves, breaks down, and removes a study drug.[1]

Trial status and size

The study is listed as Completed.[1] It enrolled 702 participants, which is a fairly large number for a single trial in this condition.[1]

Only one trial record was provided in the source data, so this article summarizes that single Albaconazole study rather than a larger trial program.[1]

Trial ID Phase Condition studied Status Enrollment
2023-504727-32-00 Phase 2 Acute vulvovaginal candidiasis Completed 702

FAQ

  • What is being studied in Albaconazole trials? The trial studies whether Albaconazole helps women with acute Candida vulvovaginitis reach clinical cure. It also looks at safety and pharmacokinetics, which means how the body absorbs and processes the study drug.
  • Who can take part in these trials? The trial includes subjects with acute vulvovaginal candidiasis. The source does not give more detailed entry rules, so exact participation criteria are not listed here.
  • What phase is the Albaconazole trial? The study is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue safety testing.
  • What treatments are compared in the trial? Albaconazole is compared with fluconazole and placebo. A placebo is a look-alike treatment with no active medicine, used to help show whether the study drug works better than no active treatment.
  • What outcome is the trial measuring? The main outcome is clinical cure, defined as a vulvovaginal score sum of 0 at the final visit. This means the study checks whether signs and symptoms have fully gone away.

Ongoing Clinical Trials on Albaconazole

  • Study on the Effectiveness of Albaconazole and Fluconazole for Treating Acute Vaginal Yeast Infections in Women

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Poland Spain

Glossary

  • Acute vulvovaginal candidiasis: A yeast infection in the vulva and vagina that causes symptoms such as irritation, discharge, and discomfort.
  • Candida vulvovaginitis: Another name used for a Candida yeast infection of the vagina and surrounding area.
  • Phase 2: A mid-stage clinical trial phase that mainly checks whether a treatment works and continues to watch safety.
  • Randomised: Participants are assigned by chance to different treatment groups, which helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team knows who gets which treatment during the trial, which helps reduce bias.
  • Placebo: A look-alike treatment with no active medicine, used as a comparison in a study.
  • Clinical cure: In this trial, it means the vulvovaginal score sum is 0 at the final visit, showing no measured signs or symptoms.
  • Vulvovaginal score sum: A score used to measure signs and symptoms in the vulva and vagina. A score of 0 means no findings were recorded.
  • Final Visit (FV): The last scheduled study visit when the main outcome is checked.
  • Pharmacokinetics: How the body absorbs, moves, breaks down, and removes a study drug.

References

  1. https://clinicaltrials.gov/study/2023-504727-32-00