StepOne Fertility
This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.
Safety and Usability
Béa Applicator and Béa Cervical Cap Device
Not Applicable
Female participants will undergo a baseline physical assessment performed by a physician at the study site. The participants will then be given the Béa Applicator and Béa Cervical Cap device with accompanying instructions and a semen collection pot. The participants will return home to use the device as per the Instruction for Use (IFU). The Béa Cervical Cap will remain in place for a minimum of 4 hours and a maximum of 6 hours. At the follow-up assessment, the investigator will investigate all primary objectives via a physical exam or via questioning the participant.
Study Type : | Interventional |
Estimated Enrollment : | 40 participants |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Béa Applicator and Béa Cervical Cap Usability Study |
Actual Study Start Date : | March 1, 2022 |
Estimated Primary Completion Date : | August 1, 2022 |
Estimated Study Completion Date : | September 30, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Single Use The participants will then be given the Béa Applicator and Béa Cervical Cap with accompanying instructions for single-use in a home use environment. |
Device: Béa Applicator and Béa Cervical Cap Device |
Ages Eligible for Study: | 18 Years to 40 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.