The effect of phytoestrogens on symptoms of premenstrual syndrome (PMS) and cognitive performance

ISRCTN ISRCTN94691299
DOI https://doi.org/10.1186/ISRCTN94691299
Secondary identifying numbers N0436118179
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
20/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L Dye
Scientific

Psychology Department
Leeds
LS2 9LN
United Kingdom

Phone +44 0113 243 1751
Email louised@psychology.leeds.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesA 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Premenstrual syndrome (PMS)
InterventionQuestionnaire. Randomised controlled trial. Random allocation to:
1. Supplementation with phytoestrogens
2. Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)phytoestrogens
Primary outcome measure1. Mood questionnaires, urine and blood test.
2. Cognitive function tests.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2002
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants50
Key inclusion criteria50 premenstrual women - university based study of staff, student volunteers and women from surrounding areas within Yorkshire.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2002
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychology Department
Leeds
LS2 9LN
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results on symptom effects 01/05/2005 Yes No