Viewing Study NCT04667858



Ignite Creation Date: 2024-05-06 @ 3:33 PM
Last Modification Date: 2025-12-16 @ 7:28 PM
Study NCT ID: NCT04667858
Status: None
Last Update Posted: 2021-04-29 00:00:00
First Post: 2020-12-08 00:00:00

Brief Title: Home Ovulation Test One Cycle at Home Study
Sponsor: SPD Development Company Limited
Organization: SPD Development Company Limited

Study Overview

Official Title: Home Ovulation Test One Cycle at Home Study
Status: None
Status Verified Date: 2021-04
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 ease of use of a Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a visual home ovulation test used to detect luteinising hormone (LH) in urine to identify when ovulation is imminent.

A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study.

This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.
Detailed Description: This study will assess the ease of use of a Home Ovulation Test when used by lay-users for one cycle in their home environment The home ovulation test to be used in the study is a visual home ovulation test used to detect luteinising hormone LH in urine to identify when ovulation is imminent

A sample size of 120 volunteers minimum will provide adequate information for assessing the usability of the home ovulation test Usability of the test will be assessed through a questionnaire completed at the end of the study

This observational study will be conducted remotely and volunteers representative of the intended user lay-users will be recruited

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None