Ignite Creation Date:
2024-05-06 @ 5:51 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05453227
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2022-06-21
Brief Title:
Zinc Containing Vaginal Topical Suppository
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Zinc Containing Vaginal Topical Suppository in Improving Post Menopausal Genitourinary Syndrome Double Blind Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
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:
The genitourinary syndrome of menopause GSM is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva vagina and lower urinary tract
The GSM includes not only genital symptoms dryness burning and irritation and sexual symptoms lack of lubrication discomfort or pain and impaired function but also urinary symptoms urgency dysuria and recurrent urinary tract infections UTI
The GSM includes not only genital symptoms dryness burning and irritation and sexual symptoms lack of lubrication discomfort or pain and impaired function but also urinary symptoms urgency dysuria and recurrent urinary tract infections UTI
Detailed Description:
The terms vulvovaginal atrophy and atrophic vaginitis were widely used until recently but they have been considered to be inadequate for referring to the constellation of symptoms and signs associated with the genitourinary system after menopause
The term vulvovaginal atrophy mentions the vulva and vagina only and these words are not used comfortably in general social discussion and in the media The term atrophic vaginitis implies a state of inflammation or infection which is not a primary component of menopausal changes In addition a limitation of the terms vulvovaginal atrophy and atrophic vaginitis is that they do not take into account the symptoms of the lower urinary tract which are among the most important symptoms related to menopause
Vulvovaginal atrophy VVA is a prevalent condition affecting many postmenopausal women1 Up to 40 of postmenopausal women develop symptoms of VVA
It is most often diagnosed by its symptoms including vaginal dryness burning itching vagina pain and dyspareunia More recently these symptoms have been described as a syndrome the genitourinary syndrome of menopause GSM
This new term describes various menopausal symptoms and signs including not only genital symptoms but sexual pain and urinary symptoms dysuria urgency as well
The pathophysiology of GSMVVA can be explained by the decline in estrogen levels associated with diminished ovarian function and natural aging
Traditionally the treatment options for GSMVVA was vaginal estrogen supplementation but many women are either unable to or are afraid to use hormones There are several non-hormonal treatment modalities for the management of VVA related symptoms especially for one of the most bothersome symptoms of vaginal dryness
The 2013 position statement of The North American Menopause Society indicates that the first-line therapies to alleviate symptoms of VVA should include non-hormonal vaginal lubricants and moisturizers as well as regular sexual activity
Although there are numerous vaginal moisturizers and lubricants are commercially available only a few of those have been tested in clinical trials
Previously the investigators showed the role of vaginal zinc supplementation on vaginal remodeling The investigators showed that in human vaginal smooth muscle cells zinc has a beneficial effect on the production of extracellular components produced by the muscle at 20 μM zinc tissue level thereby increasing the amount of elastin production
Earlier animal studies have shown that zinc plays an important role in the vaginal extracellular matrix ECM composition When rats were kept on a zinc-lacking diet the vaginal structure became similar to the menopausal vaginaWith vaginal zinc replacement the vaginal ECM could be regenerated with characteristics equivalent to juvenile rats
The term vulvovaginal atrophy mentions the vulva and vagina only and these words are not used comfortably in general social discussion and in the media The term atrophic vaginitis implies a state of inflammation or infection which is not a primary component of menopausal changes In addition a limitation of the terms vulvovaginal atrophy and atrophic vaginitis is that they do not take into account the symptoms of the lower urinary tract which are among the most important symptoms related to menopause
Vulvovaginal atrophy VVA is a prevalent condition affecting many postmenopausal women1 Up to 40 of postmenopausal women develop symptoms of VVA
It is most often diagnosed by its symptoms including vaginal dryness burning itching vagina pain and dyspareunia More recently these symptoms have been described as a syndrome the genitourinary syndrome of menopause GSM
This new term describes various menopausal symptoms and signs including not only genital symptoms but sexual pain and urinary symptoms dysuria urgency as well
The pathophysiology of GSMVVA can be explained by the decline in estrogen levels associated with diminished ovarian function and natural aging
Traditionally the treatment options for GSMVVA was vaginal estrogen supplementation but many women are either unable to or are afraid to use hormones There are several non-hormonal treatment modalities for the management of VVA related symptoms especially for one of the most bothersome symptoms of vaginal dryness
The 2013 position statement of The North American Menopause Society indicates that the first-line therapies to alleviate symptoms of VVA should include non-hormonal vaginal lubricants and moisturizers as well as regular sexual activity
Although there are numerous vaginal moisturizers and lubricants are commercially available only a few of those have been tested in clinical trials
Previously the investigators showed the role of vaginal zinc supplementation on vaginal remodeling The investigators showed that in human vaginal smooth muscle cells zinc has a beneficial effect on the production of extracellular components produced by the muscle at 20 μM zinc tissue level thereby increasing the amount of elastin production
Earlier animal studies have shown that zinc plays an important role in the vaginal extracellular matrix ECM composition When rats were kept on a zinc-lacking diet the vaginal structure became similar to the menopausal vaginaWith vaginal zinc replacement the vaginal ECM could be regenerated with characteristics equivalent to juvenile rats
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None