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Posted by on Jun 14, 2018 in Benign prostatic hyperplasia | 0 comments

In a nutshell

This study looked at the safety and effectiveness of GV1001 (Riavax) in the treatment of Benign Prostatic Hyperplasia (BPH) in men. It concluded that GV1001 could reduce symptoms of BPH without side effects.

Some background

Benign Prostatic Hyperplasia is a non-cancerous enlargement of the prostate gland. An enlarged prostate can affect bladder function and have a negative impact on quality of life. Treatments for BPH may include medication or surgery. Medications for BPH often result in many side effects while surgery can lead to complications.

GV1001 was initially a drug used in cancer treatment. However, other studies have shown it can reduce prostate size in BPH patients. It is important to research the effect of GV1001 on BPH.

Methods & findings

This study included 161 men with BPH. They were assigned to one of 4 GV1001 groups, with 3 groups of different doses of GV1001 or given the treatment at different times, and one control, placebo group (given a false treatment for comparison). In group 1 and 2, participants received 0.4mg and 0.56mg of GV1001 every 2 weeks. Prostate symptom scores were measured at the beginning, weeks 4, 8, 12, 13 and 16. In group 1 and 2, participants received 0.4mg and 0.56mg of GV1001 every 2 weeks. Group 3 received 0.56mg every 4 weeks. Secondary tests carried out were for erectile function and urine flow rate (time taken for urine to empty from the bladder.

In each of the three treatment groups, there was a reduction in prostate symptom score when compared against the score at the study’s beginning. Prostate score reduction was most significant in groups 1 and 2. In group 3, there was a reduction in score less so than groups 1 and 2. Urine flow rate was seen to improve in all treatment groups. There was a very slight increase in erectile function also.

Side effects included itchy skin, headache, and blood in the urine. These were not found to be linked to GV1001 treatment.

The bottom line

This study concluded that GV1001 treatment could improve BPH symptoms after 12 weeks.

The fine print

GV1001 does not show the side effects or need the same daily intake as more common BPH medications. GV1001’s mechanism of action in BPH treatment is still uncertain meaning there may be unknown side effects.

What’s next?

If you are interested in learning more about possible BPH treatment with GV1001 contact your doctor.

Published By :

BJU international

Date :

Apr 06, 2018

Original Title :

A Randomized, Placebo-Controlled, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients with Benign Prostatic Hyperplasia (BPH).

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