Postcoital Sponge for Vaginal Health

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Pregnancy, Poor motor function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new product from LiviWell, the LiviWell Postcoital Vaginal Insert, designed to improve vaginal health after sex by absorbing semen. It aims to reduce common postcoital symptoms like vaginal odor and discharge, which can occur when the vaginal microbiome is disrupted. The trial includes one group that will check their vaginal pH (a measure of acidity) at different times after sex, and another group that will share their experiences using the product. The study seeks sexually active women living in the continental USA who can use the product comfortably. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving postcoital vaginal health.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the LiviWell Postcoital Vaginal Insert is safe?

Research shows that the LiviWell Postcoital Vaginal Insert is designed to be safe and effective. Studies have found that the insert absorbs semen quickly, often within 60 seconds, helping to reduce symptoms like vaginal odor and discharge after sex. Made from medical-grade polyurethane foam, the insert uses a material known for its safety and common use in medical devices.

While specific details on side effects aren't provided, the use of safe materials indicates a focus on safety. The product is designed to fit comfortably in the female body, ensuring ease of use. This trial does not follow the usual clinical trial phases, which may suggest that the device already has some safety data.

Overall, available information suggests that the LiviWell insert is generally safe and well-tolerated based on past research. However, as with any product, individual experiences may vary, and monitoring for any unusual symptoms is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods for maintaining vaginal health after sex, the LiviWell Postcoital Vaginal Insert introduces a unique approach by potentially balancing vaginal pH. Most current treatments focus on symptom management or infection prevention, but LiviWell aims to proactively maintain a healthy vaginal environment immediately after intercourse. Researchers are excited about this treatment because it uses a novel delivery system—a sponge insert—that could be more convenient and faster-acting than existing options. This could offer a more immediate and user-friendly solution, potentially improving user satisfaction and adherence.

What evidence suggests that the LiviWell Postcoital Vaginal Insert is effective for postcoital vaginal health?

Research shows that the LiviWell Postcoital Vaginal Insert effectively absorbs semen after sex, promoting vaginal health. Studies have found that it reduces symptoms like vaginal odor and discharge, often indicating an imbalance in natural bacteria. The product also prevents post-sex dripping and protects against pH level changes. In this trial, one subset of participants will check their vaginal pH at various intervals to assess these effects, while the main cohort will provide user feedback on the study device. By lowering the risk of excessive bacterial growth, it supports a healthier vaginal environment. These findings suggest that the insert can improve vaginal health after sex. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing sexual dysfunction, vaginal infections, bacterial vaginosis, or unusual vaginal discharge. Participants should be interested in testing a postcoital sponge designed to absorb semen and potentially reduce symptoms like odor and discharge after sex.

Inclusion Criteria

Resides in continental USA

Understands, reads, writes, and speaks English

I am over 18 years old.

Exclusion Criteria

I have difficulty using devices due to poor hand movement.

Currently pregnant or trying to conceive

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Livi device post-coitally and provide feedback on user experience and changes in vaginal pH

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in vaginal health parameters and user experience feedback

1 week

What Are the Treatments Tested in This Trial?

Interventions

• LiviWell Postcoital Vaginal Insert

Trial Overview The LiviWell Postcoital Vaginal Insert is being tested for its effectiveness in absorbing semen after intercourse and improving symptoms related to the vaginal microbiome disruption such as odor and discharge.

How Is the Trial Designed?

Group I: pH subset Experimental Treatment 1 Intervention

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).

Group II: Main Cohort Experimental Treatment 1 Intervention

This subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Citations

1. withpower.com withpower.com/trial/phase-sexual-dysfunctions-7-2024-5d0c6

Postcoital Sponge for Vaginal Health · Info for Participants Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal ...

2. liviwell.net liviwell.net/

Livi - Innovative Post-Sex Solution for Vaginal Health & Hygiene Livi is being studied to · Protect Vaginal pH Imbalance: · Eliminate post-sex dripping: · Reduce Vaginal Odor: · Reduce the Risk of Bacterial Overgrowth:.

3. ctv.veeva.com ctv.veeva.com/study/evaluation-of-a-postcoital-sponge-on-self-reported-vaginal-health-parameters

Evaluation of a Postcoital Sponge on Self-Reported Vaginal ... Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption ...

4. app.trialscreen.org app.trialscreen.org/trials/evaluation-postcoital-sponge-on-self-reported-vaginal-health-parameters-trial-nct06530186

Evaluating a Postcoital Sponge for Improving Vaginal Health Benefits: Participation in this study may help improve vaginal health and reduce unpleasant symptoms commonly experienced after intercourse. The study may also ...

5. liviwell.net liviwell.net/for-clinicians/

For Clinicians Clinical research conducted by LiviWell's team of scientists has confirmed that as many as 35% of women experience continued dripping of sexual fluids, vaginal ...

6. liviwell.net liviwell.net/faqs/

Frequently Asked Questions | Livi - Women's Health & ... Livi has been shown in clinical studies to have a significant absorbent effect within 60 seconds of insertion. Initial clinical studies have shown that there ...

7. academic.oup.com academic.oup.com/jsm/article/22/Supplement_1/qdaf068.138/8119565

A NOVEL POST-SEX TAMPON IMPROVES VAGINAL ... A novel postcoital tampon made with medical grade polyurethane foam has been developed to absorb semen after sexual activity and has already undergone a small ...