This trial is closed for participation.

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.

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