Menstrual CyclesNCT05091658
Period Tracker Lay User Study
An observational study of Menstrual Cycles, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycles
- What is being tested?
- LH Urine Test
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2021to 10 Nov 2021
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between the ages of 18 to 45 represent the intended user of the product
Who may be able to join
- Female
- Aged 18 to 45 years
- Willing to give informed consent and comply with the investigational procedures
Who cannot join
- Used Clearblue® me Period Tracker app Persona or FAM within the last six months
- Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
- Has an immediate* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
- Is a qualified or trainee healthcare professional (HCP)
- Has professional experience of using dipstick type tests or lateral flow devices
- Currently breastfeeding, pregnant or seeking to conceive
- Currently menstruating∆ *Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.
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 assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.
- Conditions
- Menstrual Cycles
- Being tested
- LH Urine Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LH Urine TestDevice
Test for qualitative detection of LH in urine
What is being measured
The primary outcome is the main question the study is designed to answer.
Lay user usage
Ability of the lay user to perform a test and record their result
Measured: 1 hour
Secondary outcomes (1)
Comprehension of instructions for use
Ability of the lay user to understand the information provided in the instructions for use
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start14 Oct 2021
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CyclesStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Bond, Principal investigator, SPD Development CompanyRaniero Zazzeroni, Study director, SPD Development Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091658
- Sponsor's protocol ID
- PROTOCOL-1337
- Status last verified
- Nov 2021
- First submitted
- 12 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Period Tracker Lay User Study
- ClinicalTrials.gov ID
- NCT05091658
- Acronym / sponsor ID
- PROTOCOL-1337
- Conditions
- Menstrual Cycles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 25 Oct 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 assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18 to 45 represent the intended user of the product
Key inclusion criteria (3 listed)
- Female
- Aged 18 to 45 years
- Willing to give informed consent and comply with the investigational procedures
Key exclusion criteria (7 listed)
- Used Clearblue® me Period Tracker app Persona or FAM within the last six months
- Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
- Has an immediate* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
- Is a qualified or trainee healthcare professional (HCP)
- Has professional experience of using dipstick type tests or lateral flow devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LH Urine TestTest for qualitative detection of LH in urine | Device | – |
Primary outcome
Lay user usage
Time frame: 1 hour
Ability of the lay user to perform a test and record their result
1 secondary outcome
Comprehension of instructions for use
Time frame: 1 hour
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 24 Nov 2021.
- Individual participant dataSharing planned: No. No plan to share individual participant data
Related trials for Menstrual Cycles
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
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.
Sharon Bond principal investigator
SPD Development Company
Raniero Zazzeroni study director
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 Menstrual Cycles, 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 3 inclusion and 7 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 24 Nov 2021. 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?
Lay user usage (time frame: 1 hour). 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 24 Nov 2021.