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

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What is this study about?

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.

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 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 medication administration

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

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 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 Study?

  • 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

    For barrier methods like condoms and diaphragms, it is recommended to use two methods together.

Who Cannot Join the Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Gyncentrum Sp. z o.o. Katowice Poland
Hospital Universitario Y Politecnico La Fe Valencia Spain
Niepubliczny Zaklad Opieki Zdrowotnej Medem Wilk Sp. j. Katowice Poland

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Eap Osona Sud Alt Congost S.L.P. Centelles Spain
Salve Medica Sp. z o.o. S.K. Lodz Poland
Hospital Quironsalud Barcelona Barcelona Spain
Hospital Quironsalud Malaga Malaga Spain
Hospital Quironsalud Marbella Marbella Spain
Hospital Universitario Torrecardenas Almeria Spain
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain
Hm Hospitales 1989 S.A. Rivas-Vaciamadrid Spain
Hospital Quironsalud Valle Del Henares Torrejon De Ardoz Spain
D I A T R O S Diagnosticos Y Tratamientos Avanzados S.L.P. Gava Spain
Clinica Palacios Madrid S.L. Madrid Spain
Czkryiy Mfqmmobk Pkzjeiovzms Rzeszow Poland
Sllj Fpotv Sabadell Spain
Syiaorhfniludvj Pbshxqnv Gdptvkbjbuhbca Jqqzfq Toucepfdmli sspww Bialystok Poland
Hrucopou Dd Ls Sxzax Crei I Sgnh Pnr Barcelona Spain
Gwquarl Bdzxiom Mwxhvp Pxghdolh Lwnftyan Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.09.2023
Spain Spain
Not recruiting
01.09.2023

Trial locations

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.

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 ID:
2023-504727-32-00
Protocol code:
DC13ALB/2/21
Trial Phase:
Therapeutic exploratory (Phase II)

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