Menstrual Cycles
Conditions
Brief 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.
Interventions
DEVICELH Urine Test
Test for qualitative detection of LH in urine
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Aged 18 to 45 years * Willing to give informed consent and comply with the investigational procedures
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lay user usage | 1 hour | Ability of the lay user to perform a test and record their result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comprehension of instructions for use | 1 hour | Ability of the lay user to understand the information provided in the instructions for use |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lay user ability to read a high and a low result | 1 hour | Ability of the lay user to score a positive result above a baseline result using the product scoring scale |
Countries
United Kingdom
Outcome results
None listed