Skip to main content
OpenTrials
Completed

NCT Number: NCT00861588

Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that produces significant morbidity and hea1th care costs. It is likely that BPH is just as common among Chinese men. Debate exists as to whether currently available surgical and pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this condition. Evidence suggests that the consumption of soy isoflavones is related to lower rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies may include better patient compliance, improved safety and lower cost. Despite the fact that soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism of action, no randomised control trial has been performed using isoflavones to treat BPH. Therefore, a randomised control trial is proposed to test the tolerability and effectiveness of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will be reviewed every three months with maximal urine flow rate, international prostate symptoms score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize that this intervention will reduce lower urinary tract symptoms and slow the progression of the disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese ethnicity
  • Age between 45-85 years
  • Diagnosed to have watchful waiting BPH (Qmax< 15 ml/sec together with a voided volume of more than 150 mls)
  • Not on any concurrent alternative medications for BPH
  • Mentally capable to give informed written consent and willing to comply with study requirements

Exclusion criteria

  • Prefers to have conventional medical or surgical treatment for BPH
  • Concurrent treatment for unstable chronic diseases including unstable angina, poorly controlled DM (HbA1c >7.5), less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year)
  • Known to have prostate cancer or kidney and/or liver failure
  • Urinary symptoms due to known causes other than BPH including neurogenic bladder, urinary tract infection, bladder cancer, bladder stone, urethral stricture
  • Previous history of prostatic surgery
  • Illiterate or having difficulty in filling in a patient diary

Treatment and study plan

isoflavones (Soylife 25)

Drug

40mg of soy isoflavones capsule (once daily)

Other names: Soylife 25

Placebo

Drug

starch placebo

Primary outcomes

  1. The primary safety endpoint is tolerability i.e. discontinuation due to an adverse event. The primary efficacy outcome will be an improvement in the urine flow rate by at least 2ml/sec after 12 months treatment when compared to placebo.

    Time frame: 12 months

  2. The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in the International Prostate Symptom Score (IPSS) and Sf-36 respectively.

    Time frame: 12 months

Secondary outcomes

  1. The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in IPSS and Sf-36 respectively.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • School of Pharmacy, CUHK

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 13, 2009
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.