Menopause Sample Collection

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.

Study Overview

• Status: Completed
• Conditions: Menopause

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development Company Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy female volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of daily urine samples collected from women during various stages of the menopause	Daily urine samples collected	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause Symptom Information	Daily recording of experience of a range of menopause symptoms	3 months

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Principal Investigator: Jackie Boxer, SPD Development Company; Study Director: Raniero Zazzeroni, SPD Development Company

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No