Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT01948258
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2013-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Sponsor:
SPD Development Company Limited
Organization:
Study Overview
Official Title:
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.
Detailed Description:
The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and luteinising hormone (LH) in women's urine. This personal information allows women to identify their fertile window and appropriately time intercourse in order to maximise their chances of conception. A new version of this monitor (Clearblue Advanced Fertility Monitor) has been developed with additional functionality including the option to test for pregnancy.
This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility Monitor and the understanding and interpretation of the results by the user. This is a single centre clinical study which will be conducted by volunteers at their residence and co-ordinated by the clinical department at SPD Development Company Ltd.
A minimum of 100 female volunteers representing the target consumer will be required to use the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This will involve them setting up the monitor, using the monitor for one full cycle and then setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant result.
At the end of one full cycle, all volunteers will complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results.
This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility Monitor and the understanding and interpretation of the results by the user. This is a single centre clinical study which will be conducted by volunteers at their residence and co-ordinated by the clinical department at SPD Development Company Ltd.
A minimum of 100 female volunteers representing the target consumer will be required to use the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This will involve them setting up the monitor, using the monitor for one full cycle and then setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant result.
At the end of one full cycle, all volunteers will complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: