Menopause Sample Collection

Completed

• Conditions: Menopause

• Registration Number: NCT04853472
• Lead Sponsor: SPD Development Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-18
• Study Start: 2021-04-19
• Study First Posted: 2021-04-21
• Primary Completion: 2022-01-05
• Study Completion: 2023-03-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of daily urine samples collected from women during various stages of the menopause	3 months	Daily urine samples collected

Secondary Outcome Measures

Name	Time	Method
Menopause Symptom Information	3 months	Daily recording of experience of a range of menopause symptoms

Trial Locations

Locations (1)

SPD Development Company Ltd; 🇬🇧 Bedford, Bedfordshire, United Kingdom