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Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

This study has been completed.
Information provided by:
University of Kansas Medical Center Identifier:
First received: January 3, 2008
Last updated: May 10, 2011
Last verified: May 2011
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer

Condition Intervention Phase
Prostate Cancer
Dietary Supplement: Flav-ein capsules
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • efficacy of using isoflavones as safer alternative to synthetic estrogens [ Time Frame: 16 Weeks ]

Enrollment: 11
Study Start Date: August 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects receive supplement
Dietary Supplement: Flav-ein capsules
Soy/isoflavone supplementation
Placebo Comparator: 2
Subjects will receive placebo
Drug: Placebo

Detailed Description:
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.)
  • had biochemical/clinical relapse and started on antiandrogens
  • have documented history of hot flashes

Exclusion Criteria:

  • History of MI, DVT, CVA
  • peanut allergy
  • untreated hypothyroidism
  • must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00594620

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Principal Investigator: Jeffrey M. Holzbeierlein, MD University of Kansas Medical Center
  More Information

Responsible Party: Jeffrey M. Holzbeierlein, MD, University of Kansas Medical Center Identifier: NCT00594620     History of Changes
Other Study ID Numbers: 9639
Study First Received: January 3, 2008
Last Updated: May 10, 2011

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017