SPL7013-018Starpharma Phase 3 study of VivaGel® in Bacterial Vaginosis

• Research type

  Research Study

• Full title

  A phase 3, double blind, multicentre, randomised, placebo controlled study to determine the efficacy and safety of SPL7013 Gel (VivaGel®) to prevent the recurrence of bacterial vaginosis.

• IRAS ID

  152790

• Contact name

  Phillip Hay

• Contact email

  phay49@gmail.com

• Sponsor organisation

  Starpharm Pty Ltd

• Eudract number

  2014-000694-39

• Research summary

  A study to determine the effectiveness and safety of SPL7013 Gel (VivaGel®) to prevent the returning symptoms of bacterial vaginosis.

  Starpharma, the sponsor of this study, are studying an investigational drug called 1% SPL7013 Gel. This study drug will be administered to see if it will reduce the number of episodes of Bacterial Vaginosis that the participants experience. This study will also look at how safe and well-tolerated the study drug is, and how it affects the participants well-being.

  Participants must be between the ages of 18 and 45 years old and have a history of recurrent bacterial vaginosis (BV) and are currently experiencing BV. Bacteria are organisms that are too small to see with your naked eye and exist in almost all environments in the world, including your body. There are good bacteria and there are harmful bacteria. Bacterial vaginosis is caused by an imbalance of the normal bacterial environment in your vagina, and results in vaginal irritation, discharge and malodour. The cause for this imbalance is unknown.

  This study will involve about 620 women and is planned to be conducted in about 50 study centres in the Americas, Europe and Thailand.

  If participants are eligible to participate in this study, they will be randomised (like tossing a coin) to one of two study treatment groups listed below:

  • Group A: 1% SPL7013 Gel
  • Group B: Placebo Gel

  A placebo is a ‘dummy treatment’, which looks like the real medicine but it does not contain any active ingredients. Neither the participant nor your study doctor will know which treatment the participant will receive. The participant has an equal chance to be in either group.
  

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  14/LO/1468

• Date of REC Opinion

  15 Oct 2014

• REC opinion

  Further Information Favourable Opinion