Trial Outcomes & Findings for Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study (NCT NCT01948258)

NCT ID: NCT01948258

Last Updated: 2018-11-02

Results Overview

Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 395 participants
• Primary outcome timeframe: one month use
• Results posted on: 2018-11-02

Participant Flow

This study was conducted by volunteers remotely and managed by the clinical department at SPD. For the study, 395 females aged between 18-45 years were recruited via internet advertising and from women who had participated in previous SPD studies. The first volunteer was recruited on 1st March 2013, the last was recruited on 1st August 2013.

Volunteers were instructed to test for pregnancy prior to starting the study. If pregnant before the start of their cycle they were withdrawn and classified as a pre-study pregnancy. Volunteers were also withdrawn if identified as health care professionals.

Participant milestones

Measure	Fertility Monitor Use of Clearblue Advanced Fertility Monitor
Overall Study STARTED	395
Overall Study COMPLETED	233
Overall Study NOT COMPLETED	162

Reasons for withdrawal

Measure	Fertility Monitor Use of Clearblue Advanced Fertility Monitor
Overall Study Pregnancy	41
Overall Study Did not complete by cut-off date	35
Overall Study Lost to Follow-up	27
Overall Study Withdrawal by SPD	8
Overall Study Withdrawal by Subject	6
Overall Study Health Care Professional	43
Overall Study Removed from statistical analysis	2

Baseline Characteristics

Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study

Baseline characteristics by cohort

Measure	Fertility Monitor n=233 Participants Use of Clearblue Fertility Monitor
Age, Customized Age of Participants · 18-25	38 Participants n=5 Participants
Age, Customized Age of Participants · 26-30	68 Participants n=5 Participants
Age, Customized Age of Participants · 31-35	64 Participants n=5 Participants
Age, Customized Age of Participants · 36-40	56 Participants n=5 Participants
Age, Customized Age of Participants · 41-45	7 Participants n=5 Participants
Sex: Female, Male Female	233 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian : Bangladeshi	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian : Chinese	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian : Indian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian : Pakistani	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian : South Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian : Other Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black: African	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black: Caribbean	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black: Other Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White: American	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White: Australian/New Zealander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White: Eastern European	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White: Mediterranean/Middle Eastern	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White: Western European	210 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White: Other White	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Mixed	0 Participants n=5 Participants
Highest qualification Post-graduate qualifications	25 Participants n=5 Participants
Highest qualification Degree or equivalent (college degree)	77 Participants n=5 Participants
Highest qualification Other higher education below degree level (associa	20 Participants n=5 Participants
Highest qualification A levels, vocational level 3 and equivalents (age	55 Participants n=5 Participants
Highest qualification GCSE (Grade A*-C), vocational level 2 and equivale	41 Participants n=5 Participants
Highest qualification Qualifications at level 1 and below	2 Participants n=5 Participants
Highest qualification Other qualifications	8 Participants n=5 Participants
Highest qualification No qualifications	5 Participants n=5 Participants
Occupation Managerial	23 Participants n=5 Participants
Occupation Professional	59 Participants n=5 Participants
Occupation Associate Professional / Technical	27 Participants n=5 Participants
Occupation Administrative / Secretarial	24 Participants n=5 Participants
Occupation Skilled Trade	4 Participants n=5 Participants
Occupation Personal Services	8 Participants n=5 Participants
Occupation Sales / Customer Services	29 Participants n=5 Participants
Occupation Manufacturing / Driver	0 Participants n=5 Participants
Occupation Support Personnel	11 Participants n=5 Participants
Occupation Student	4 Participants n=5 Participants
Occupation Homemaker	32 Participants n=5 Participants
Occupation Other	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: one month use

Population: Volunteers whose data contributes to the full analysis set.

Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.

Outcome measures

Measure	Fertility Monitor n=233 Participants Use of Clearblue Fertility Monitor
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting	89.7 percentage of participants

SECONDARY outcome

Timeframe: one month

Population: Volunteers who completed the study, who had daily diary entries and monitor download data for days on which a test was conducted

To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands.

Outcome measures

Measure	Fertility Monitor n=228 Participants Use of Clearblue Fertility Monitor
Correct Identification of Monitor Status	91.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: one month

Population: Volunteers who completed the study, comparison of Clearblue Fertility Monitor pregnancy test results and a marketed pregnancy test. Results for all tests conducted.

Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration.

Outcome measures

Measure	Fertility Monitor n=329 Participants Use of Clearblue Fertility Monitor
Pregnancy Test Result Monitor test result in agreement with predicate	99.3 percentage of tests in agreement Interval 97.6 to 99.9
Pregnancy Test Result Monitor test result in agreement with hCG levels	100 percentage of tests in agreement Interval 98.8 to 100.0

Adverse Events

Fertility Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Sarah Johnson, Head of Clinical and Regulatory Affairs

SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd

Phone: 01234835486

Email: sarah.johnson@spdspark.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place