Menopause Sample Collection

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Menopause

Study type: Observational

Funder types: Industry

Identifiers

NCT04853472

PROTOCOL-1326

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

151 participants in 3 patient groups

Early Stage Peri-Menopause

Description:

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

Description:

Late stage peri-menopause: Irregular cycles with prolonged periods of amenorrhea \>60 days in length (but less than 12 months)

Post-Menopause

Description:

Greater than 12 months since last menstrual period