Menopause Sample Collection

NCT04853472 | Completed

• 1 other identifier: PROTOCOL-1326
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• Number of daily urine samples collected from women during various stages of the menopause

  Daily urine samples collected

  3 months

Secondary Outcomes (1)

• Menopause Symptom Information

  3 months

Study Arms (3)

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

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy female volunteers

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Samples

Study Officials

• Raniero Zazzeroni

  SPD Development Company

  STUDY DIRECTOR

• Jackie Boxer

  SPD Development Company

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 21, 2021
• Study Start: April 19, 2021
• Primary Completion: January 5, 2022
• Study Completion: March 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)