The effect of phytoestrogens on symptoms of premenstrual syndrome (PMS) and cognitive performance
| ISRCTN | ISRCTN94691299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94691299 |
| Protocol serial number | N0436118179 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- 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
Scientific
Psychology Department
Leeds
LS2 9LN
United Kingdom
| Phone | +44 0113 243 1751 |
|---|---|
| louised@psychology.leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | phytoestrogens |
| Primary outcome measure(s) |
1. Mood questionnaires, urine and blood test. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 50 |
| Key inclusion criteria | 50 premenstrual women - university based study of staff, student volunteers and women from surrounding areas within Yorkshire. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Psychology Department
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
