Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530186
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
LiviWells consumer hygiene device is a post-coital vaginal insert called Livi Livi is comprised of an applicator with a medical-grade polyurethane foam and retrieval string It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal The result is a decrease in dischargedripping and vaginal odor The investigators also believe the device will lower vaginal pH as the typical premenopausal vaginal pH is acidic pH 4 and semen has an alkaline pH 8 The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor dripping discomfort Furthermore the risk of bacterial vaginosis BV is higher in women who are sexually active and not using male condoms The investigators have additional studies planned to evaluate if the product lowers the risk of BV
The current study will be used to validate user needs requirements for the study device understand pH changes after insertion and evaluate change in symptoms of vaginal odor dischargedripping and discomfort common symptoms of vaginal microbiome disruption and bacterial vaginosis
The current study will be used to validate user needs requirements for the study device understand pH changes after insertion and evaluate change in symptoms of vaginal odor dischargedripping and discomfort common symptoms of vaginal microbiome disruption and bacterial vaginosis
Study Oversight
Has Oversight DMC:
None
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?:
None