MenopauseNCT04853472
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 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 151 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2021to 1 Mar 2023
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy female volunteers
Who may be able to join
- 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
Who cannot join
- 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 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.
- Conditions
- Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of daily urine samples collected from women during various stages of the menopause
Daily urine samples collected
Measured: 3 months
Secondary outcomes (1)
Menopause Symptom Information
Daily recording of experience of a range of menopause symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start19 Apr 2021
- Primary completion5 Jan 2022
- Study completion1 Mar 2023
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
- 151 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
- NCT04853472
- Sponsor's protocol ID
- PROTOCOL-1326
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause Sample Collection
- ClinicalTrials.gov ID
- NCT04853472
- Acronym / sponsor ID
- PROTOCOL-1326
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 21 Apr 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | –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 |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy female volunteers
Key inclusion criteria (8 listed)
- Female
- Between the ages of 45 and 60 years
- Suspects they are going through or have been through the menopause
- Experiencing cycle irregularities:
- Willing to give informed consent
Key exclusion criteria (5 listed)
- 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)
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 daily urine samples collected from women during various stages of the menopause
Time frame: 3 months
Daily urine samples collected
1 secondary outcome
Menopause Symptom Information
Time frame: 3 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 Dec 2023.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Menopause
Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
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 8 inclusion and 5 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 Dec 2023. 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 daily urine samples collected from women during various stages of the menopause (time frame: 3 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 Dec 2023.