Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes