Extension for Menopause Sample Collection

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.

Completed

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Key information

Conditions

Menopause

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326

Exclusion criteria

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)

Treatment and study plan

Primary outcomes

Number of Urine Samples Collected

Time frame: Daily samples for 10 days at 0, 6 and 12 months

Daily Urine Samples

Secondary outcomes

Menopause Symptom Questionnaire

Time frame: 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)

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 14, 2023
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed