NCT05091658

Completed

Period Tracker Lay User Study

SPD Development Company Limited Source

Other study identifiers

Sponsor study identifier

PROTOCOL-1337

Study Type

observational

Actual enrollment (reported)

120

Locations

1 country

Sites

1

Timeline

Study Start

October 14, 2021

Actual (reported)

Primary Completion

November 10, 2021

Actual (reported)

Study Completion

November 10, 2021

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 120 participants
Study completion date: November 10, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 12, 2021
Actual (reported)
Study Start
October 14, 2021
Actual (reported)
First Posted
October 25, 2021
Actual (reported)
Primary Completion
November 10, 2021
Actual (reported)
Study Completion
November 10, 2021
Actual (reported)

Last Updated: November 24, 2021
Status Verified: November 2021
Last Update Submitted: November 23, 2021

Conditions

Menstrual Cycles

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Comprehension of instructions for use
1 hour

Other Outcomes (1)

Lay user ability to read a high and a low result
1 hour

Interventions

LH Urine TestDevice

Test for qualitative detection of LH in urine

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsFemales are representative of the intended user of the product

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Sponsors & Collaborators

SPD Development Company Limited
Industrylead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Study Officials

Sharon Bond
SPD Development Company
PRINCIPAL INVESTIGATOR
Raniero Zazzeroni
SPD Development Company
STUDY DIRECTOR

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 25, 2021

Study Start

October 14, 2021

Actual (reported)

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Unknown

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Completed

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Not ApplicableCompleted

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Menstrual Cycle and Platelet-rich Fibrin

Unknown

NCT03908320

Menstrual Phase and Smoking Cessation at a State Quitline

Not ApplicableCompleted

NCT06750250

The Effects of Aerobic Exercise During the Different Phases of Menstural Cycle

Not ApplicableRecruiting

Female

Aged 18 to 45 years

Willing to give informed consent and comply with the investigational procedures

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

November 10, 2021

Actual (reported)

Study Completion

November 10, 2021

Actual (reported)

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05091658
Data provider: ClinicalTrials.gov
Source updated: 2021-11-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:31 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations