Extension for Menopause Sample Collection

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Menopause

Study type: Observational

Funder types: Industry

Identifiers

NCT06171373

PROTOCOL-1415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)