Vaginal DischargeNCT04885556
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
A study testing Tampon-like device for absorption of sexual fluids in people with Vaginal Discharge and Dyspareunia, run by Atlantic Health System at 1 site in United States.
Trial summary
Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Discharge, Dyspareunia, Female Sexual Dysfunction
- What is being tested?
- Tampon-like device for absorption of sexual fluids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 15 Sep 2021
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Heterosexual
- Age 25-50
- Has used tampons in the past 5 years
- Sexually active (vaginal intercourse, minimum once per week)
- Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day"
- Willing and able to use product
- Understands, reads, writes, and speaks English
Who cannot join
- Pregnant
- Currently using condoms
- Unable to use device due to poor motor function
- Chronic disease which makes prone to infection (diabetes, autoimmune)
- Recurrent yeast infections
- Recurrent Urinary tract infection (UTI) (>2 within the past year)
Show all 9Show fewer
- Diagnosis of pelvic organ prolapse (Stage II or greater)
- Previous pelvic or vaginal surgery which, in the opinion of the investigator, may prevent proper use of product
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Center for Specialized Women's Health, division of Garden State Urology
Denville, New Jersey, 07834
Cynthia Evaniecki, 973-537-5557, cevaniecki@gsunj.com
mingber@gsunj.com
About this study
Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.
Read the detailed description
Despite the significant number of sexual dysfunctions in women, physicians often avoid discussing these concerns in the office setting. With recent research on the role of the pelvic floor, and recently approved medical therapies for hypoactive sexual desire disorder, physicians have begun to adapt to questioning patients about libido and pain-related sexual dysfunctions. However, pain-related sexual questionnaires often focus on insertional and penetrational dyspareunia, without asking about discomfort minutes, hours, or even the day following sexual intercourse. One common compliant in ambulatory sexual medicine clinics is the bothersome dripping, odor, and discomfort women experience after sexual activity when no condom is used, and when intravaginal ejaculation occurs.
Previous studies have shown the effects of semen on alterations in the vaginal flora. These changes contribute to a multitude of clinical complaints and diagnoses, including malodor, continuous discharge after intercourse, and bacterial vaginosis (BV). The exposure of semen changes the vaginal flora by increasing the pH levels, in turn altering the bacterial growth pattern. This implies the persistent presence of semen in the vagina may be one of the causes of malodor and development of BV. Chvapil utilized gas chromatography and demonstrated that the longer period of time semen was present in the vagina, the more likely it resulted in a strong and unattractive vaginal odor. Gallo showed that an incidental diagnosis of BV was correlated with detection of sperm on gram stain, and frequent coitus with or without condom use.
The investigator's goal in this study is to evaluate a novel postcoital consumer health product and its effects on the complaints of continuous seepage of semen and vaginal odor after intercourse.
- Being tested
- Tampon-like device for absorption of sexual fluids
- Keywords
- vaginal discharge, dripping, vaginal odor
- Medical subject headings
- Vaginal Discharge, Dyspareunia, Vaginitis, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tampon-like device for absorption of sexual fluidsDevice
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
| Study group | Role | What they receive |
|---|---|---|
| Immediate Use | Experimental | Subjects in this arm will be instructed to use the study device for 2 minutes and remove Receives: Device: Tampon-like device for absorption of sexual fluids |
| 1 hour use | Experimental | Subjects in this arm will be instructed to use the product for one hour and then remove Receives: Device: Tampon-like device for absorption of sexual fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Improvement (PGI-I)
Validated Questionnaire
Measured: within 1 hour of use of product
Weight of Investigational Device
Product weight (amount of fluid absorbed)
Measured: within 1 hour of use of product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start5 Apr 2021
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DischargeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects to be placed into one of two study groups, 1) immediate use and 2) 1 hour use
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04885556
- Sponsor's protocol ID
- AC-004
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
- ClinicalTrials.gov ID
- NCT04885556
- Acronym / sponsor ID
- AC-004
- Keywords
- vaginal discharge, dripping, vaginal odor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 13 May 2021 (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.
Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.
Detailed description
Despite the significant number of sexual dysfunctions in women, physicians often avoid discussing these concerns in the office setting. With recent research on the role of the pelvic floor, and recently approved medical therapies for hypoactive sexual desire disorder, physicians have begun to adapt to questioning patients about libido and pain-related sexual dysfunctions. However, pain-related sexual questionnaires often focus on insertional and penetrational dyspareunia, without asking about discomfort minutes, hours, or even the day following sexual intercourse. One common compliant in ambulatory sexual medicine clinics is the bothersome dripping, odor, and discomfort women experience after sexual activity when no condom is used, and when intravaginal ejaculation occurs.
Previous studies have shown the effects of semen on alterations in the vaginal flora. These changes contribute to a multitude of clinical complaints and diagnoses, including malodor, continuous discharge after intercourse, and bacterial vaginosis (BV). The exposure of semen changes the vaginal flora by increasing the pH levels, in turn altering the bacterial growth pattern. This implies the persistent presence of semen in the vagina may be one of the causes of malodor and development of BV. Chvapil utilized gas chromatography and demonstrated that the longer period of time semen was present in the vagina, the more likely it resulted in a strong and unattractive vaginal odor. Gallo showed that an incidental diagnosis of BV was correlated with detection of sperm on gram stain, and frequent coitus with or without condom use.
The investigator's goal in this study is to evaluate a novel postcoital consumer health product and its effects on the complaints of continuous seepage of semen and vaginal odor after intercourse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects to be placed into one of two study groups, 1) immediate use and 2) 1 hour use
| Arm | Type | Receives |
|---|---|---|
| Immediate Use | Experimental | Device: Tampon-like device for absorption of sexual fluidsSubjects in this arm will be instructed to use the study device for 2 minutes and remove |
| 1 hour use | Experimental | Device: Tampon-like device for absorption of sexual fluidsSubjects in this arm will be instructed to use the product for one hour and then remove |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Heterosexual
- Age 25-50
- Has used tampons in the past 5 years
- Sexually active (vaginal intercourse, minimum once per week)
- Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day"
Key exclusion criteria (9 listed)
- Pregnant
- Currently using condoms
- Unable to use device due to poor motor function
- Chronic disease which makes prone to infection (diabetes, autoimmune)
- Recurrent yeast infections
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 |
|---|---|---|
| Tampon-like device for absorption of sexual fluidsSubjects will insert a tampon-like device to absorb sexual fluids after intercourse | Device | 1 hour use, Immediate Use |
Primary outcome
Patient Global Impression of Improvement (PGI-I)
Time frame: within 1 hour of use of product
Validated Questionnaire
Weight of Investigational Device
Time frame: within 1 hour of use of product
Product weight (amount of fluid absorbed)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- 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 Tampon-like device for absorption of sexual fluids in people with Vaginal Discharge and Dyspareunia, 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 7 inclusion and 9 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 13 May 2021. 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?
Contact Cynthia Evaniecki (973-537-5557, cevaniecki@gsunj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Improvement (PGI-I) (time frame: within 1 hour of use of product). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2021.