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.

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Key information

Conditions

Menopause

Age range

45 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Primary outcomes

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

Time frame: 3 months

Daily urine samples collected

Secondary outcomes

Menopause Symptom Information

Time frame: 3 months

Daily recording of experience of a range of menopause symptoms

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Apr 21, 2021
Registry last updated: Dec 13, 2023

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