Menopause
Conditions
Brief summary
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 -80˚C 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.
Interventions
None listed
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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: * 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: 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 * Willing to give informed consent
Exclusion criteria
* 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 daily urine samples collected from women during various stages of the menopause | 3 months | Daily urine samples collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Symptom Information | 3 months | Daily recording of experience of a range of menopause symptoms |
Countries
United Kingdom
Outcome results
None listed