Contact information
Type
Scientific
Primary contact
Dr L Dye
ORCID ID
Contact details
Psychology Department
Leeds
LS2 9LN
United Kingdom
+44 0113 243 1751
louised@psychology.leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436118179
Study information
Scientific title
Acronym
Study hypothesis
A randomised double blind, placebo controlled trial of the effects of supplementation of phytoestrogens (PO) (isoflavones - 100 mg/day) on premenstrual symptoms and cognitive performance in 50 women with at least mild premenstrual symptoms for two menstrual cycles per condition is proposed. The main objective is to determine whether PO are more beneficial than placebo supplements in relieving symptoms of PMS and to assess whether the consumption of PO affects cognitive performance in the premenstrual and follicular phases of the menstrual cycle.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and Genital Diseases: Premenstrual syndrome (PMS)
Intervention
Questionnaire. Randomised controlled trial. Random allocation to:
1. Supplementation with phytoestrogens
2. Placebo
Intervention type
Drug
Phase
Not Specified
Drug names
phytoestrogens
Primary outcome measures
1. Mood questionnaires, urine and blood test.
2. Cognitive function tests.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2002
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
50 premenstrual women - university based study of staff, student volunteers and women from surrounding areas within Yorkshire.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2002
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Department
Leeds
LS2 9LN
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results on symptom effects on http://www.ncbi.nlm.nih.gov/pubmed/15975174
Publication citations
-
Results on symptom effects
Bryant M, Cassidy A, Hill C, Powell J, Talbot D, Dye L, Effect of consumption of soy isoflavones on behavioural, somatic and affective symptoms in women with premenstrual syndrome., Br. J. Nutr., 2005, 93, 5, 731-739.