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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acute vulvovaginal candidiasis, a common yeast infection that affects the vaginal area, causing symptoms like itching, burning, and irritation. The study will compare the effectiveness and safety of a new medication called Albaconazole (also known by its code name UR-9825) with another medication, Fluconazole, and a placebo. Both Albaconazole and Fluconazole are taken as hard capsules by mouth.

The purpose of the study is to determine how well different single doses of Albaconazole work in treating the infection compared to a placebo. Participants will be randomly assigned to receive either Albaconazole, Fluconazole, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are not biased.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The main goal is to see if the symptoms of the infection are completely resolved by the end of the study. The trial will help researchers understand the best dose of Albaconazole for treating acute vulvovaginal candidiasis and compare its effectiveness to Fluconazole and a placebo.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to have acute vulvovaginal candidiasis. This is determined by the presence of two or more symptoms such as itching, burning, or redness, with at least one symptom being moderate in intensity.

    A rapid antigen test and a positive culture for Candida species are required before starting the treatment.

  2. Step 2

    Treatment allocation

    The participant is randomly assigned to receive either a single dose of albaconazole, fluconazole, or a placebo. The specific dosage of albaconazole is determined as part of the study's objectives.

  3. Step 3

    Medication administration

    The medication is administered orally in the form of a hard capsule. The participant takes the assigned single dose as directed.

  4. Step 4

    Monitoring and follow-up

    The participant's symptoms are monitored throughout the study period. The primary goal is to assess the clinical cure, defined as a vulvovaginal score sum of zero at the final visit.

    The study aims to compare the effectiveness of albaconazole against the placebo in achieving this clinical cure.

  5. Step 5

    Final visit

    At the final visit, the participant's symptoms are evaluated to determine the outcome of the treatment. The percentage of participants achieving a clinical cure is recorded for analysis.

Who can join the trial?

14 criteria

  • Must be a female who has started menstruating.
  • Must have been diagnosed with **acute Candida vulvovaginitis**, which is a type of yeast infection. This diagnosis requires:
    • Having two or more symptoms like itching, burning, irritation, swelling, redness, or skin damage, with at least one symptom being of moderate intensity. Symptoms are rated as 0 for absent, 1 for mild, 2 for moderate, and 3 for severe.
    • A positive result on a rapid test for **Candida**, which is a type of yeast.
    • A vaginal pH level of 4.5 or lower.
    • The diagnosis must be confirmed by a positive culture test for **Candida**. A swab for this test must be taken before starting the trial treatment.
    • Must provide written consent freely after understanding the trial and how data will be used.
    • If able to become pregnant, must use highly effective birth control methods. These can include:
      • Male or female condoms
      • Diaphragms
      • Combined hormonal contraception (like pills, vaginal rings, or patches) that stops ovulation
      • Progestogen-only hormonal contraception (like pills, injections, or implants) that stops ovulation
      • Intrauterine device (IUD)
      • Intrauterine hormone-releasing system
      • Surgical methods like having tubes tied or a partner who has had a vasectomy
      • Choosing not to have sexual intercourse during the trial period

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups that might need special protection, like pregnant women or people with certain disabilities.
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Investigated drugs

  • Albaconazole

    is an investigational medication being studied for its effectiveness in treating acute Candida vulvovaginitis, a type of yeast infection. The trial aims to determine how well a single dose of albaconazole works in curing the infection compared to other treatments.

  • Fluconazole

    is a commonly used antifungal medication that is being used in this trial as a comparison to albaconazole. It is typically prescribed to treat yeast infections, including Candida vulvovaginitis, and helps to stop the growth of the yeast causing the infection.

What is already known about the treatment

  • Albaconazole

    Albaconazole is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating acute vulvovaginal candidiasis, a common yeast infection. The medication works by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes, thereby disrupting the cell membrane and leading to the death of the fungus. Albaconazole is classified as an antifungal agent and is being compared to fluconazole and placebo in ongoing research to determine its safety and efficacy.

  • Fluconazole

    Fluconazole is an oral antifungal medication commonly used to treat various fungal infections, including acute vulvovaginal candidiasis. It is well-established in medical practice and literature as an effective treatment option. Fluconazole works by inhibiting the enzyme lanosterol 14-alpha-demethylase, which is crucial for the production of ergosterol, an essential component of fungal cell membranes. This disruption leads to the breakdown of the fungal cell membrane, effectively treating the infection.

Investigated diseases

Acute vulvovaginal candidiasis – This is a common yeast infection caused by the overgrowth of Candida species, primarily Candida albicans, in the vaginal area. It typically presents with symptoms such as itching, burning, and a thick, white vaginal discharge. The condition can cause discomfort and irritation in the vulva and vagina. It often occurs when the natural balance of bacteria and yeast in the vagina is disrupted. Factors such as antibiotic use, hormonal changes, or a weakened immune system can contribute to its development. The infection is usually acute, meaning it appears suddenly and can be quite intense.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504727-32-00Protocol codeDC13ALB/2/21Estimated enrolment702 patientsSponsorPalau Pharma S.L.

sourced from the EU Clinical Trials Register and site verification

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