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A clinical study for bacterial vaginosis

Gender Female

Age from 18 up to and including 60

The purpose of the study is to investigate if the Gedea Pessary is effective and safe to treat bacterial vaginosis.

Bacterial vaginosis is caused by bacterial overgrowth and may affect most women at some time. The infection can cause foul- smelling vaginal discharge and sometimes vaginal itching and a burning sensation while urinating. There are several medications for bacterial vaginosis, but most of them contain antibiotics and they are not always effective, which means that the infection recurs.

Criteria for participation

  • To participate in this study, you must be 18 years or older, have started your periods and have a confirmed bacterial vaginosis diagnosis.
  • If you are pregnant, breast-feeding or planning to get pregnant within the 18 weeks study period, you can not participate.

The treatment that will be evaluated, the Gedea Pessary, is a vaginal pessary that contains a naturally occurring substance involved in the metabolism of glucose and also an approved food additive. This substance has been shown to counteract the emergence of so-called biofilm, which is a structure of proteins and sugars formed by fungi and bacteria that facilitates bacteria to cause infection.”

To find out if the treatment with Gedea Pessary is effective, it will be given to patients who have bacterial vaginosis problems. The study will also find out if the treatment is safe and how you as a patient experience the treatment.

A total of 150 women in Europe will participate in the study and all will be treated with vaginal pessaries either containing active substance (Gedea Pessary) or inactive substance (placebo).

The study is financed by and carried out on the initiative of Gedea Biotech AB in Lund, Sweden, and has been reviewed and approved by the national Regulatory Authority and Independent Ethics Committee.

 

Take a taxi, Uber or the bus to the clinic to avoid parking problems. Costs for travel will be reimbursed if you keep your receipt.

There is a token of appreciation for participants in the NEFERTITI study. It is £ 10 for completion of Day 7, £ 20 for completion of Day 63, and £ 40 for completion of the follow up period at Day 128.

 

How to apply

If you would like to learn more about the study and whether you may be able to take part, please register on this website and answer the questions below. If you might  be eligible, we will contact you by phone and discuss the study in more detail with you and answer any questions you may have.

If you participate in the study, you will need to visit a study site at least 3 times

  • Male
  • Female

You will receive an email which you must confirm

DD-MM-YYYY (e.g. 07-12-2021)

  • No
  • Yes

  • Fishy odour
  • None of the above
  • Increased vaginal discharge

  • I hereby give Link2Trials my consent to store the personal data I have provided in my personal profile and to process them for the purposes stated in the declaration of consent. View these here.

    Full privacy statement

     

    What data do we collect?
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    These personal data are necessary for the intended and actual performance of an agreement. Without this information, we will not be able to enter into an agreement or use you as a trial subject. In addition, we will ask you for your prior consent to process of these data.

    Research purposes: ‘special personal data’
    In addition, certain information is requested for research purposes in order to see whether you are a match with the trial in question and to carry out the study. This information includes personal data with respect to your gender, age, ethnicity, level of education, medication use, fertility, height and weight, alcohol consumption, smoking habits, and other medical data and/or data concerning health.

    A large part of this information is ‘special personal data’ in the sense of the GDPR. Because this information is sensitive, we treat it with care. These data will only be processed with your explicit consent.

    PRIVACY STATEMENT

    March 2021

    www.link2trials.uk

     

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