Menopause
Conditions
Brief summary
This study will provide urine samples from women going through the menopause transition in order to maintain the SPD sample bank. Symptom information and cycle length will also be recorded to observe how these change through the menopause transition.
Detailed description
This is an extension to a previous sample collection (Protocol-1326) where additional samples will be collected from the women who continue to go through the menopausal transition (i.e. are not post-menopausal). Three sets of 10 consecutive daily urine samples will be collected at three timepoints (month 0, month 6 and month 12). Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.
Interventions
None listed
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326
Exclusion criteria
* Post-menopausal volunteers (12 months since last menstrual period) * Use of hormone replacement therapy (HRT) * Use of hormone contraception * Hysterectomy and/or oophorectomy * Pregnant or breast feeding * Other medical reason for amenorrhea (absence of menstruation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Urine Samples Collected | Daily samples for 10 days at 0, 6 and 12 months | Daily Urine Samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Symptom Questionnaire | Recorded at 0, 6 and 12 months | Experience of a range of menopause symptoms on a 5-point scale (where 1 is very mild and 5 is very severe) |
Countries
United Kingdom
Outcome results
None listed