Vaginal InfectionNCT06530186
Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
A study testing LiviWell Postcoital Vaginal Insert in people with Vaginal Infection and Vaginal Discharge, run by Atlantic Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection, Vaginal Discharge, Vaginosis
- What is being tested?
- LiviWell Postcoital Vaginal Insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 (for pH subset, 18-45)
- Sexually-active with biological men
- Willing and able to use product
- Resides in continental USA
- Understands, reads, writes, and speaks English
Who cannot join
- Currently Pregnant or are trying to conceive
- Unable to use device due to poor motor function
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Garden State Urology
Mountain Lakes, New Jersey, 07046
Cathy Smith, MA, 973-537-5557, csmith@gsunj.com
Michael Ingber, MD
About this study
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.
Read the detailed description
LiviWell's 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 discharge/dripping 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, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.
- Conditions
- Vaginal Infection, Vaginal Discharge, Vaginosis, Sexual Dysfunction
- Being tested
- LiviWell Postcoital Vaginal Insert
- Keywords
- vaginal odor, vaginal discharge, postcoital dripping, vaginal microbiome
- Medical subject headings
- Vaginitis, Vaginal Discharge, Vaginal Diseases, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiviWell Postcoital Vaginal InsertDevice
Also called Livi
subjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.
| Study group | Role | What they receive |
|---|---|---|
| pH subset | Experimental | This subset of patients (n=100) will be checking their vaginal pH at various time intervals (before, 2-6 hours after, and 10-14 hours after sex). Receives: Device: LiviWell Postcoital Vaginal Insert |
| Main Cohort | Experimental | This subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH Receives: Device: LiviWell Postcoital Vaginal Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Experience Questionnaire
Validation of User Needs Requirements as well as patient experience
Measured: 24 hours
Secondary outcomes (1)
change in vaginal pH
change in vaginal pH before and after using Livi, and before and after NOT using Livi
Measured: 2-6 hours, and 10-14 hours after use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Ingber, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530186
- Sponsor's protocol ID
- AC-005
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ingber M, Ackerman AL, Rubin R, Sobel R. Patient Satisfaction With a Novel Postcoital Intravaginal Fluid-Absorbing Device. O G Open. 2026 Jul 30;3(4):e190. doi: 10.1097/og9.0000000000000190. eCollection 2026 Aug.
PubMed 42541233
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
- ClinicalTrials.gov ID
- NCT06530186
- Acronym / sponsor ID
- AC-005
- Conditions
- Vaginal Infection, Vaginal Discharge, Vaginosis, Sexual Dysfunction
- Keywords
- vaginal odor, vaginal discharge, postcoital dripping, vaginal microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
LiviWell's 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 discharge/dripping 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, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pH subset | Experimental | Device: LiviWell Postcoital Vaginal InsertThis subset of patients (n=100) will be checking their vaginal pH at various time intervals (before, 2-6 hours after, and 10-14 hours after sex). |
| Main Cohort | Experimental | Device: LiviWell Postcoital Vaginal InsertThis subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 (for pH subset, 18-45)
- Sexually-active with biological men
- Willing and able to use product
- Resides in continental USA
- Understands, reads, writes, and speaks English
Key exclusion criteria (3 listed)
- Currently Pregnant or are trying to conceive
- Unable to use device due to poor motor function
- Unable to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiviWell Postcoital Vaginal InsertAlso: Livisubjects will use Livi within minutes of completion of sex, and will remove study device in under an hour. | Device | Main Cohort, pH subset |
Primary outcome
User Experience Questionnaire
Time frame: 24 hours
Validation of User Needs Requirements as well as patient experience
1 secondary outcome
change in vaginal pH
Time frame: 2-6 hours, and 10-14 hours after use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 42541233Ingber M, Ackerman AL, Rubin R, Sobel R. Patient Satisfaction With a Novel Postcoital Intravaginal Fluid-Absorbing Device. O G Open. 2026 Jul 30;3(4):e190. doi: 10.1097/og9.0000000000000190. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiviWell Postcoital Vaginal Insert in people with Vaginal Infection and Vaginal Discharge, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Experience Questionnaire (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06530186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.