Extension for Menopause Sample Collection

SPD Development Company Limited34 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Menopause

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

SPD Development Company Ltd

Bedford, Bedfordshire, United Kingdom

Outcomes

Primary Outcomes

Number of Urine Samples Collected

Daily Urine Samples

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

Secondary Outcomes

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)

Time frame: Recorded at 0, 6 and 12 months

Data from ClinicalTrials.gov

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