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Study on the Effectiveness and Safety of Metronidazole, Neomycin Sulfate, and Nystatin for Women with Bacterial Vaginosis and Yeast Infections

Verified siteRegistered drugNo placebo

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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 two common vaginal infections: bacterial vaginosis and vulvovaginal candidiasis. Bacterial vaginosis is an infection caused by an imbalance of bacteria in the vagina, while vulvovaginal candidiasis is a yeast infection. The study will compare the effectiveness and safety of two treatments: Metronidazole/Neomycin Sulfate/Nystatin pessaries and Tergynan vaginal tablets. Both treatments are designed to be used vaginally to help clear these infections.

The purpose of the study is to determine if the Metronidazole/Neomycin Sulfate/Nystatin pessaries are as effective and safe as the Tergynan vaginal tablets in treating these infections. Participants in the study will use one of these treatments for a period of 10 days. During this time, researchers will monitor the participants to see how well the infections respond to the treatment and to check for any side effects. The study aims to provide a better understanding of which treatment option is more effective in achieving a cure for these infections.

Participants will be asked to follow specific guidelines during the study, such as avoiding certain activities and products that could interfere with the treatment. The study will help determine the best treatment option for women suffering from bacterial vaginosis and vulvovaginal candidiasis, potentially leading to improved care and outcomes for these common conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of bacterial vaginosis (BV) or vulvovaginal candidiasis (VVC).
A negative pregnancy test is required for women of childbearing potential, and reliable contraception must be practiced during the study.
Step 2
Treatment initiation
The treatment involves the use of either Metronidazole/Neomycin Sulfate/Nystatin pessaries or Tergynan vaginal tablets.
The medication is administered vaginally once daily for a duration of 10 days.
Step 3
Treatment period
During the 10-day treatment period, abstain from sexual intercourse and alcohol consumption.
Refrain from using any intra-vaginal products such as douches, feminine sprays, or tampons.
Step 4
Follow-up visits
Follow-up visits are scheduled to assess the clinical and microbiological cure of BV or VVC.
The primary goal is to achieve a therapeutic cure, which includes both clinical and microbiological/mycological cure.
Step 5
Evaluation of outcomes
The study evaluates the proportion of participants achieving symptom relief and the need for additional treatment.
Adverse events are monitored throughout the study to ensure safety.
Step 6
Completion of study
The study concludes with a final assessment to determine the sustainability of the therapeutic cure.
Participants' experiences and outcomes contribute to the overall evaluation of the treatment's efficacy and safety.

Who can join the trial?

14 criteria

Must be a female patient diagnosed with either bacterial vaginosis (BV) or vulvovaginal candidiasis (VVC).
For BV, diagnosis is based on specific criteria like vaginal discharge, a positive whiff test, vaginal pH greater than 4.5, and presence of clue cells. Confirmation is done with a Nugent score of seven or higher.
For VVC, diagnosis is based on the presence of certain fungal structures and a vaginal pH of 4.5 or less, along with symptoms like itching, burning, or irritation.
Must be a woman who has started menstruating, aged between 18 and 50 years.
Should be in general good health according to medical history and examinations.
Must have regular menstrual cycles, with intervals between 21 to 35 days.
Must be willing to provide written consent before any study procedures.
If capable of having children, must have a negative pregnancy test at the start of the study.
Must agree to use reliable birth control methods from 28 days before the study until 30 days after treatment. Certain methods like the NuvaRing® are not allowed.
Must have had a normal Pap test or a specific negative result for HPV in the last 3 years.
Must agree to avoid sexual intercourse for the first 10 days of the study and use a non-lubricated condom afterward.
Must agree not to drink alcohol during the 10-day treatment and for 1 day after.
Must agree not to use any products inside the vagina during the study, such as douches or tampons.
Must be willing and able to follow the study requirements as determined by the investigator.

Who cannot join the trial?

4 criteria

Patients who are not female cannot participate.
Patients who do not have **bacterial vaginosis (BV)** or **vulvovaginal candidiasis (VVC)** cannot participate. BV is an infection caused by an imbalance of bacteria in the vagina, and VVC is a yeast infection in the vagina.
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 cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.

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Verified sites

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Spitalul Clinic De Obstetrica Ginecologie Cuza Voda Iasi
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Iasi, Romania

Trial locations

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Investigated drugs

Metronidazole
is an antibiotic used to treat infections caused by bacteria and certain parasites. In this trial, it is used in combination with other medications to treat vaginitis, which is an inflammation of the vagina.
Neomycin Sulfate
is another antibiotic that helps to stop the growth of bacteria. It is used in this study as part of a combination treatment for vaginitis to ensure a broad range of bacterial infections are addressed.
Nystatin
is an antifungal medication that is used to treat infections caused by fungi. In this trial, it is included in the treatment to help eliminate fungal infections that may be contributing to vaginitis.
Tergynan
is a combination medication in the form of vaginal tablets. It is used to treat various types of vaginitis by targeting both bacterial and fungal infections. This medication is being compared to the combination of Metronidazole, Neomycin Sulfate, and Nystatin in the study to evaluate its effectiveness and safety.

What is already known about the treatment

Metronidazole/Neomycin Sulfate/Nystatin
This medication is administered as pessaries, which are inserted into the vagina. It is currently being studied in clinical trials to assess its safety and effectiveness compared to Tergynan® vaginal tablets. The main therapeutic indications include treating bacterial vaginosis and vulvovaginal candidiasis. Metronidazole works by disrupting DNA synthesis in bacteria, Neomycin Sulfate inhibits protein synthesis, and Nystatin binds to sterols in fungal cell membranes, causing cell leakage. It is classified as an antimicrobial and antifungal combination medication.
Tergynan®
This medication is administered as vaginal tablets, inserted into the vagina. It is being compared in clinical trials to a combination of Metronidazole, Neomycin Sulfate, and Nystatin for treating specific and non-specific vaginitis. The main therapeutic indications are bacterial vaginosis and vulvovaginal candidiasis. Tergynan® contains a combination of active ingredients that work by disrupting the growth of bacteria and fungi, providing relief from infection symptoms. It is classified as an antimicrobial and antifungal medication.

Investigated diseases

Bacterial Vaginosis
Bacterial vaginosis is a common vaginal condition caused by an imbalance of the natural bacteria found in the vagina. It often results in a thin, grayish-white discharge with a fishy odor. The condition may cause itching or irritation, but some women experience no symptoms at all. It is not considered a sexually transmitted infection, although it can be associated with sexual activity. The condition can fluctuate, with symptoms sometimes resolving on their own. Recurrence is common, and it can affect women of all ages.
Vulvovaginal Candidiasis
Vulvovaginal candidiasis, also known as a yeast infection, is a fungal infection of the vagina and vulva caused by the overgrowth of Candida species, typically Candida albicans. It is characterized by itching, irritation, and a thick, white, cottage cheese-like discharge. The condition can cause discomfort during urination or intercourse. It is not classified as a sexually transmitted infection, although it can be triggered by factors such as antibiotic use, hormonal changes, or a weakened immune system. Symptoms can vary in severity and may recur, affecting women of all ages.