Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04885556
Status:
UNKNOWN
Last Update Posted:
2021-05-13
First Post:
2021-04-28
Brief Title:
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
Sponsor:
Atlantic Health System
Organization:
Atlantic Health System
Study Overview
Official Title:
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None