Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A double-blind, randomised, dose-finding trial to assess the efficacy, safety and pharmacokinetics of a single dose of albaconazole versus fluconazole and placebo in the treatment of acute Candida vulvovaginitis

This research study is investigating a new medication called albaconazole for treating acute vaginal thrush, also known as vulvovaginal candidiasis. We want to see how effective and safe albaconazole is compared to a commonly used thrush medicine, fluconazole, and a placebo (a dummy pill with no active medicine). The study is also designed to find the best dose of albaconazole. Participants will be women aged 18 and over who have thrush. By comparing these treatments, researchers hope to find a new and effective way to help women recover from this common condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Palau Pharma S.L.

Enrolment target

702

Start

18 Sep 2023

Acute vulvovaginal candidiasis

What is this study about?

Vaginal thrush, also known as vulvovaginal candidiasis, is a very common infection that can cause itching, soreness, and irritation in and around the vagina. It's caused by an overgrowth of yeast, a type of fungus. While there are treatments available, researchers are always looking for new and potentially better options.

This particular study is focusing on a new medicine called albaconazole. It's being compared with fluconazole, which is a medicine already commonly used to treat thrush, and a placebo. A placebo is a dummy pill that looks just like the study medication but doesn't contain any active drug. This helps researchers understand if the new medicine is genuinely having an effect, or if improvements are due to other factors.

The main aim of this study is to see how well albaconazole works in clearing up the symptoms of thrush. Researchers will also be checking its safety and looking at how the body handles the medicine. By carefully studying different doses of albaconazole, they hope to find the most effective and safe amount to recommend for future use. This is a vital step in developing new treatments that could help many people.

Key takeaways

This study is testing a new medicine for vaginal thrush.
It compares the new medicine to an existing one and a dummy pill.
The goal is to find the best dose and check safety.
Participants will be women aged 18 or older with thrush.
You will receive careful medical monitoring if you join.

Who may be eligible?

This study is looking for women who have acute vaginal thrush. To be considered, you need to be at least 18 years old. There's no upper age limit, so women of all adult ages are welcome to inquire.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female?
Are you 18 years old or older?
Do you have a current episode of vaginal thrush?
Are you able to attend clinic visits as required?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the new medicine (albaconazole), the existing medicine (fluconazole), or a placebo (dummy pill). You won't know which one you're taking, and neither will the study team – this is called a 'double-blind' study and helps ensure fair results. You will take a single dose of the allocated medication.

Your participation will likely involve a few visits to the study clinic. At these visits, doctors and nurses will assess your thrush symptoms and overall health. They will also collect samples (like blood) to check how the medicine is working and for safety. The total duration of your involvement in the study will be determined by how long it takes to monitor your recovery after taking the single dose of medication.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the new medicine, albaconazole, is effective in treating your thrush symptoms. You will also receive careful medical attention throughout the study. However, there's a possibility you might receive a placebo and therefore not get active treatment for your thrush during the study. All medicines can have side effects, and some may be serious. The study team will carefully monitor you for any potential side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Poland

Common questions

What is 'double-blind'?

It means neither you nor the doctors will know if you're getting the study medicine, the existing medicine, or a dummy pill. This helps keep the results fair.

What is a placebo?

A placebo is a pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps us compare the real medicine's effects.

Will I get paid to participate?

The study information doesn't specify payment, but you should ask the study team if there's any reimbursement for your time or travel expenses.

How long will I be in the study?

The study involves a single dose of medicine, and your participation will last for the monitoring period afterwards. The study team will give you specific details.

What is 'acute vulvovaginal candidiasis'?

This is the medical term for a sudden or recent episode of vaginal thrush.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.