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Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00861588
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : March 13, 2009
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Benign Prostate Hyperplasia Drug: isoflavones (Soylife 25) Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: isoflavones
Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive isoflavones
Drug: isoflavones (Soylife 25)
40mg of soy isoflavones capsule (once daily)
Other Name: Soylife 25
Placebo Comparator: starch
Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive placebo
Drug: placebo
starch placebo

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861588

Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
School of Pharmacy, CUHK
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William CW wong, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00861588     History of Changes
Other Study ID Numbers: CUHK4453/05M
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by Chinese University of Hong Kong:
complementary & alternative medicine
randomized control trial
quality of life
benign prostate hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male