MenopauseNCT06171373
Extension for Menopause Sample Collection
An observational study of Menopause, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2024to 7 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy female volunteers
Who may be able to join
- Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
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.
- Conditions
- Menopause
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Urine Samples Collected
Daily Urine Samples
Measured: 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)
Measured: Recorded at 0, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start22 Jan 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raniero Zazzeroni, Study director, SPD Development CompanyJackie Boxer, Principal investigator, SPD Development Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171373
- Sponsor's protocol ID
- PROTOCOL-1415
- Status last verified
- May 2025
- First submitted
- 6 Dec 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension for Menopause Sample Collection
- ClinicalTrials.gov ID
- NCT06171373
- Acronym / sponsor ID
- PROTOCOL-1415
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy female volunteers
Key inclusion criteria (1 listed)
- Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Urine Samples Collected
Time frame: Daily samples for 10 days at 0, 6 and 12 months
Daily Urine Samples
1 secondary outcome
Menopause Symptom Questionnaire
Time frame: Recorded at 0, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raniero Zazzeroni study director
SPD Development Company
Jackie Boxer principal investigator
SPD Development Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by SPD Development Company Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Urine Samples Collected (time frame: Daily samples for 10 days at 0, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.