RecruitingNAINTERVENTIONAL

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

This study aims to find out if a new gel, called Multi-Gyn ActiGel Plus, is effective in treating a common vaginal infection called Bacterial Vaginosis (BV). We want to see how it compares to a 'placebo' gel, which looks and feels the same but contains no active medicine. Participants will be randomly given either the Multi-Gyn ActiGel Plus or the placebo, and they won't know which one they are using. They will apply the gel twice a day for seven days. Researchers will then check on their progress about three weeks after starting treatment, and follow up with a phone call around five weeks after starting. Each person's involvement in the study will last roughly five weeks.

At a glance

Status

Recruiting

Phase

Sponsor

BioClin BV

Enrolment target

200

Start

11 Jun 2021

Estimated completion

01 Dec 2026

Bacterial Vaginoses

What is this study about?

Many women experience Bacterial Vaginosis, or BV, which is a common vaginal infection. It happens when there's an imbalance of the natural bacteria in the vagina, leading to symptoms like unusual discharge, odour, and discomfort. This study is exploring a new way to treat BV using a product called Multi-Gyn ActiGel Plus. The goal is to see if this gel can effectively help women with BV feel better and clear up the infection.

To make sure the results are fair and reliable, this study is designed in a special way. It's called 'randomised' because participants are put into groups by chance, like flipping a coin, so it's not up to the researchers. It's also 'double-blind', meaning that neither the participants nor the doctors and nurses know who is getting the Multi-Gyn ActiGel Plus and who is getting a 'placebo' gel. A placebo gel looks identical but doesn't have any active medicine. This helps ensure that any changes we see are truly due to the active gel and not because people expect to feel better.

By comparing the new gel to a placebo, we can get a clear picture of whether Multi-Gyn ActiGel Plus really works better than no treatment. This kind of research is very important because it helps us understand which treatments are most effective and safe for common health problems like BV. The results of studies like this help doctors make the best recommendations for their patients in the future.

Key takeaways

This study is testing a new gel (Multi-Gyn ActiGel Plus) for Bacterial Vaginosis (BV).
It compares the new gel to a dummy gel (placebo) to see if it works.
Participants will use the gel for 7 days and be followed for about 5 weeks.
Neither you nor the researchers will know if you're getting the active gel or the placebo.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for women who are at least 18 years old and have been diagnosed with Bacterial Vaginosis (BV). You would need to be able to understand and sign a consent form, showing you agree to take part, and be willing to follow the study's schedule of appointments and check-ups.

There are certain reasons why you might not be able to join the study. For example, if you currently have another type of vaginal infection, a sexually transmitted infection, or certain serious health conditions like cancer. You also wouldn't be able to participate if you're pregnant, breastfeeding, or trying to get pregnant. If you've recently used antibiotics or other treatments for vaginal conditions, or if you're allergic to any ingredients in the study treatment, you would also not be eligible.

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 a woman aged 18 or over?
Have you been diagnosed with Bacterial Vaginosis (BV)?
Are you currently pregnant, breastfeeding, or trying to get pregnant?
Do you have any other vaginal infections or serious health conditions?
Have you used antibiotics or other vaginal treatments recently (in the last 14 days)?
Are you able to attend follow-up appointments and phone calls?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to one of two groups: either you'll receive the Multi-Gyn ActiGel Plus or a placebo gel (a dummy gel with no active medicine). You won't know which one you're getting. You will need to apply the gel into your vagina twice a day for seven days in a row.

After you start the treatment, you'll have a check-up visit about three weeks later. For those who show signs of improvement at this visit, there will be a follow-up phone call about five weeks after you started. Your total involvement in the study, from beginning to end, will last about five weeks.

Potential risks and benefits

Taking part in this study might offer a potential benefit if you receive the active Multi-Gyn ActiGel Plus gel and it helps treat your Bacterial Vaginosis. However, there's also a chance you could receive the placebo gel, which won't treat your BV. As with any new treatment, there's always a small risk of side effects, though the gels are generally considered safe. You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Praxis Dr. Peters
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is Bacterial Vaginosis (BV)?

BV is a common imbalance of bacteria in the vagina, which can cause symptoms like unusual discharge, smell, and discomfort.

What is a 'placebo'?

A placebo is a dummy treatment that looks and feels like the active medicine but doesn't contain any active ingredients. It helps researchers see if the real medicine is effective.

Will I know if I'm getting the real gel or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know which gel you are using until after the study is over.

How long will I need to use the gel?

You will need to apply the gel twice a day for 7 consecutive days.

How long will I be involved in the study?

Your total participation in the study, including follow-up, will be around 5 weeks.

How to find out more

Diana Zeneli, MD

diana.pasho@karopharma.com 0031614706949 Official trial record

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