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Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN42940165
Date of registration:	30/01/2004
Prospective Registration:	No
Primary sponsor:	Medical Research Council (UK)
Public title:	Red clover-derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial
Scientific title:
Date of first enrolment:	01/05/1997
Target sample size:	205
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN42940165
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Sheila A. Bingham
Address:	MRC Dunn Human Nutrition Unit CB2 2XY Cambridge United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Women aged 49 - 65 years
2. Wolfe's P2 or DY (dense parenchyma) mammographic breast patterns
Exclusion criteria: Not provided at time of registration.

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Breast cancer
Cancer
Breast cancer

Intervention(s)

Red clover-derived isoflavone tablet (26 mg biochanin A, 16 mg formononetin, 1 mg genistein and 0.5 mg daidzein) or placebo.

Primary Outcome(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(s)

Not provided at time of registration

Secondary ID(s)

N/A

Source(s) of Monetary Support

Novogen Ltd (Australia), Medical Research Council (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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