Menopause Sample Collection

Menopause Clinical Trial

Official title:

Menopause Sample Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853472
• Other study ID #: PROTOCOL-1326
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2023
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 1, 2023
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Menopause

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 daily urine samples collected from women during various stages of the menopause	Daily urine samples collected	3 months
Secondary	Menopause Symptom Information	Daily recording of experience of a range of menopause symptoms	3 months