CClinicalTrials.gg
CompletedNCT06171373Updated May 13, 2025

Extension for Menopause Sample Collection

An observational study in Menopause, sponsored by SPD Development Company Limited. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by SPD Development Company Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Menopause
03

In context

Lead sponsor

SPD Development Company Limited is the lead sponsor of 30 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy female volunteers

Inclusion criteria

  • Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Number of Urine Samples Collected

    Daily Urine Samples

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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • SPD Development Company Ltd
    Bedford, Bedfordshire MK44 3UP, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06171373
Lead sponsor
SPD Development Company Limited
Responsible party
Sponsor
First posted
Dec 14, 2023
Start date
Jan 22, 2024
Primary completion
May 7, 2025
Completion
May 7, 2025
Last update
May 13, 2025

Study contacts

Raniero Zazzeroni
study director · SPD Development Company
Jackie Boxer
principal investigator · SPD Development Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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