Cervical Cap Insemination
Conditions
Keywords
Cervical cap insemination, Usability Study
Brief summary
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.
Detailed description
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.
Interventions
None listed
Sponsors
Rinovum Women's Health, Inc.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, any ethnicity * 20 - 45 years of age * Sexually active * Signed Informed Consent
Exclusion criteria
* Prior surgery to the cervix or vaginal tract * Vaginal prolapse * Cervical cancer * Hysterectomy * History of Toxic Shock Syndrome (TSS)
Countries
United States
Outcome results
None listed