NCT06171373

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

December 6, 2023

Last Update Submit

May 12, 2025

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

  • Number of Urine Samples Collected

    Daily Urine Samples

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

Secondary Outcomes (1)

  • Menopause Symptom Questionnaire

    Recorded at 0, 6 and 12 months

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy female volunteers

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Samples

Study Officials

  • Raniero Zazzeroni

    SPD Development Company

    STUDY DIRECTOR

  • Jackie Boxer

    SPD Development Company

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

January 22, 2024

Primary Completion

May 7, 2025

Study Completion

May 7, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)