Status:
COMPLETED
Menopause Sample Collection
Lead Sponsor:
SPD Development Company Limited
Conditions:
Menopause
Eligibility:
FEMALE
45-60 years
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04853472
Start Date
April 19 2021
End Date
March 1 2023
Last Update
December 13 2023
Active Locations (1)
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1
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP