Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAtlantic Health System
About this trial
LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Over 18 (for pH subset, 18-45)
Sexually-active with biological men
Willing and able to use product
Resides in continental USA
Disqualifiers
Currently Pregnant or are trying to conceive
Unable to use device due to poor motor function
Unable to sign informed consent
Trial design
Design model
Single group
Treatments tested in this trial
LiviWell Postcoital Vaginal Insert
Devicesubjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: pH subsetExperimental treatment 1 intervention
Group B: Main CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
User Experience Questionnaire
Validation of User Needs Requirements as well as patient experience
Time frame
24 hoursSecondary outcomes
1
change in vaginal pH
change in vaginal pH before and after using Livi, and before and after NOT using Livi
Time frame
2-6 hours, and 10-14 hours after useSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: