NCT05088382

Completed

Period Tracker at Home Study

SPD Development Company Limited Source

Other study identifiers

Sponsor study identifier

PROTOCOL-1339

Study Type

observational

Actual enrollment (reported)

126

Locations

1 country

Sites

1

Timeline

Study Start

August 4, 2021

Actual (reported)

Primary Completion

November 3, 2021

Actual (reported)

Study Completion

November 3, 2021

Actual (reported)

Brief Summary

This study will assess the usability of a Period Tracker product when used by lay users in their own homes.

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): 126 participants
Study completion date: November 3, 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.

Study Start
August 4, 2021
Actual (reported)
First Submitted
October 12, 2021
Actual (reported)
First Posted
October 21, 2021
Actual (reported)
Primary Completion
November 3, 2021
Actual (reported)
Study Completion
November 3, 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)

Usability of the Period Tracker device when used at home
Number of users scoring 3 or less on a 7 point Likert scale for various questions related to usability of the Period Tracker device after use at home
28 days (approximately 1 menstrual cycle)

Interventions

LH Urine TestDevice

Test for the qualitative measurement 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 the intended user of this 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

Jackie Boxer
SPD Development Company
PRINCIPAL INVESTIGATOR
Raniero Zazzeroni
SPD Development Company
STUDY DIRECTOR

Enrollment

126 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 21, 2021

Study Start

August 4, 2021

Actual (reported)

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Unknown

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Not ApplicableRecruiting

Female

Aged 18 to 45 years

Menstrual cycles are 21-60 days long

Seeking to predict when her next period will start

Seeking to give informed consent and comply with the investigational procedures

Has a compatible iPhone with internet access that they are willing to use for the study (iPhone 7+ and iOS 13 and above)

You may not qualify if:

Currently pregnant or breastfeeding
Used Clearblue® me (Period Tracker app), Persona Contraception Monitor or Clearblue Advanced Fertility Monitor 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
Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
Using hormone replacement medications containing LH or hCG (e.g. Pregnyl®)
Is currently seeking to conceive
Has been diagnosed with polycystic ovarian syndrome (PCOS)
Has PCOS symptoms e.g. very irregular cycles, hirsutism \*Immediate relatives are defined as parents, children, siblings or partner/spouse

Contact the study team to confirm eligibility.

Primary Completion

November 3, 2021

Actual (reported)

Study Completion

November 3, 2021

Actual (reported)

Last Updated

November 24, 2021

Record last verified: 2021-11

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: NCT05088382
Data provider: ClinicalTrials.gov
Source updated: 2021-11-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:49 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary 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:

Source record

Locations