Period Tracker Lay User Study | NCT05091658

Studies
Period Tracker Lay User Study

NCT05091658

Sponsor

SPD Development Company Limited

Status

Completed

Last Update Posted

Nov 24, 2021Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Menstrual Cycles

Interventions

LH Urine Test

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2021Actual

Primary Completion Date

Nov 10, 2021Actual

Completion Date

Nov 10, 2021Actual

First Submitted Date

Oct 12, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2021

Last Update Posted Date

Nov 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Name	Type	Description	Arm Group Labels	Other Names
LH Urine Test	Device	Test for qualitative detection of LH in urine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lay user usage	Ability of the lay user to perform a test and record their result	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Comprehension of instructions for use	Ability of the lay user to understand the information provided in the instructions for use	1 hour

Other Outcomes

Measure	Description	Time Frame
Lay user ability to read a high and a low result	Ability of the lay user to score a positive result above a baseline result using the product scoring scale	1 hour

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females are representative of the intended user of the product

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women between the ages of 18 to 45 represent the intended user of the product

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Bond	SPD Development Company	Principal Investigator
Raniero Zazzeroni	SPD Development Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SPD Development Company Ltd		Bedford	Bedfordshire	MK44 3UP	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share individual participant data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided