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This study will provide daily urine samples from women during early and late stage peri-menopause as well as post-menopause over the course of three calendar months in order to maintain the SPD sample bank.
Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80ËšC until required.
Symptom information will also be recorded to determine whether there are any noticeable physiological changes that can be related to stage of the menopause.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Stage Peri-Menopause | Mild cycle irregularity over the last 3-6months (minimum), variation of >6 days in length between consecutive cycles including shortened and longer cycles (but not >60 days in length) | ||
| Late Stage Peri-Menopause | Late stage peri-menopause: Irregular cycles with prolonged periods of amenorrhea >60 days in length (but less than 12 months) | ||
| Post-Menopause | Greater than 12 months since last menstrual period |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of daily urine samples collected from women during various stages of the menopause | Daily urine samples collected | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause Symptom Information | Daily recording of experience of a range of menopause symptoms | 3 months |
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Inclusion Criteria:
Female
Between the ages of 45 and 60 years
Suspects they are going through or have been through the menopause
Experiencing cycle irregularities:
Willing to give informed consent
Exclusion Criteria:
Female only
Healthy female volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Raniero Zazzeroni | SPD Development Company | Study Director |
| Jackie Boxer | SPD Development Company | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPD Development Company Ltd | Bedford | Bedfordshire | MK44 3UP | United Kingdom |
No plan to share IPD
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Urine Samples