Dose finding study of effect of GTx-758 on testosterone levels in men

• Research type

  Research Study

• Full title

  Open label, dose finding study of the effect of GTx-758 on testosterone levels in men

• IRAS ID

  42914

• Contact name

  Ulrike Lorch

• Sponsor organisation

  GTx Inc

• Eudract number

  2009-017898-37

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Prostate cancer is a disease in which cancer develops in the prostate gland, an organ which is part of the male reproductive system. Prostate cancer is one of the most frequently diagnosed cancers in males and it is one of the most common causes of cancer deaths in males. It also causes pain, problems with urinating and impotence. Current drugs available for patients who suffer from prostate cancer cause many unpleasant side effects and therefore there is a need for the development of a new drug that will be effective against this condition and that will be better tolerated. This study will involve a new drug, GTx-758, which is thought to work against prostate cancer, by reducing the testosterone levels in the body. Before this drug can be given to patients with this condition, it is very important to find out how long it stays in the body, how well it is tolerated and how well the body handles continuous dosing of the study drug. The study drug has already been tested in 2 different studies, the second of these where GTx-758 was given once a day for 10 consecutive days. Data from the previous studies as well as data obtained from pre-clinical tests (in the lab and on animals) is used to give the researchers an idea of how and at what doses this drug should be given to humans. The data is also used to provide an indication of the possible side effects, such as a possibility of lowered or loss of libido, the study drug may cause. This study is to see how well the body handles having the same dose of GTx-758 every day for up to 28 consecutive days.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  09/IEC04/11

• Date of REC Opinion

  25 Jan 2010

• REC opinion

  Further Information Favourable Opinion