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NCT06171373 Clinical Trial

Extension for Menopause Sample Collection

Menopause Clinical Trial

Official title:
Extension for Menopause Sample Collection

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06171373
Other study ID # PROTOCOL-1415
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 22, 2024
Est. completion date March 2025

Study information
Verified date March 2024
Source SPD Development Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 34
Est. completion date March 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom SPD Development Company Ltd Bedford Bedfordshire

Sponsors (1)
Lead Sponsor Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Urine Samples Collected Daily Urine Samples Daily samples for 10 days at 0, 6 and 12 months
Secondary Menopause Symptom Questionnaire Experience of a range of menopause symptoms on a 5-point scale (where 1 is very mild and 5 is very severe) Recorded at 0, 6 and 12 months
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