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Red clover-derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial
DOI 10.1186/ISRCTN42940165
ClinicalTrials.gov identifier
EudraCT number
Public title Red clover-derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis To determine the effects of taking a red clover-derived isoflavone supplement daily for one year on mammographic breast density. Effects on oestradiol, follicle-stimulating hormone (FSH), luteinising hormone (LH), lymphocyte tyrosine kinase activity and menopausal symptoms were also assessed.
Lay summary Not provided at time of registration
Ethics approval All study procedures were approved by the Dunn Human Nutrition Unit Ethics Committee, and the Cambridge Local Research Ethics Committee.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Breast cancer
Participants - inclusion criteria 1. Women aged 49 - 65 years
2. Wolfe's P2 or DY (dense parenchyma) mammographic breast patterns
Participants - exclusion criteria Not provided at time of registration.
Anticipated start date 01/05/1997
Anticipated end date 31/12/1999
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 205
Interventions Red clover-derived isoflavone tablet (26 mg biochanin A, 16 mg formononetin, 1 mg genistein and 0.5 mg daidzein) or placebo.
Primary outcome measure(s) Change in:
1. Mammographic breast density
2. Serum oestradiol, FSH and LH
3. Menopausal symptoms
4. Lymphocyte tyrosine kinase activity

Measured from baseline to 12 months.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Novogen Ltd (Australia)
2. Medical Research Council (UK)
Trial website
Publications 1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15084240
Contact name Dr  Sheila A.  Bingham
  Address MRC Dunn Human Nutrition Unit
  City/town Cambridge
  Zip/Postcode CB2 2XY
  Country United Kingdom
Sponsor Medical Research Council (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
Date applied 30/01/2004
Last edited 02/10/2012
Date ISRCTN assigned 30/01/2004
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