Extension for Menopause Sample Collection
- Conditions
- Menopause
- Registration Number
- NCT06171373
- Lead Sponsor
- SPD Development Company Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
- Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Urine Samples Collected Daily samples for 10 days at 0, 6 and 12 months Daily Urine Samples
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
SPD Development Company Ltd
🇬🇧Bedford, Bedfordshire, United Kingdom