Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 12:24 AM
Study NCT ID:
NCT05434351
Status:
TERMINATED
Last Update Posted:
2023-07-28
First Post:
2022-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcome of Chinese Women With Genitourinary Syndrome of Menopause Treated With Vaginal Dehydroepiandrosterone
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
A Review on the Clinical Outcome of Chinese Women With Moderate to Severe Symptoms of Genitourinary Syndrome of Menopause (GSM) Treated With Vaginal Dehydroepiandrosterone (DHEA)
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inadequate sample and only few patients were prescribed with vaginal DHEA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Genitourinary syndrome of menopause (GSM) is a common condition with prevalence was up to 80%. Symptoms associated with GSM include vaginal or vulvar dryness, itchiness, dyspareunia, increased urinary frequency or urgency and dysuria. Although the symptoms are disturbing and causing a significant negative impact on quality of life, it is observed that only a minority of the women receive proper treatment. Treating these GSM-associated symptoms properly is important because these symptoms usually persist with time, unlike vasomotor symptoms of menopause which may subside spontaneously with time.
The clinical efficacy and metabolism of vaginal DHEA has been evaluated in western population. However, there is lack of local data on the effectiveness of vaginal DHEA in treating Chinese women with GSM. Therefore, we aim at evaluating the clinical outcome of our participants who have moderate to severe symptoms of GSM who has been treated with vaginal DHEA.
The clinical efficacy and metabolism of vaginal DHEA has been evaluated in western population. However, there is lack of local data on the effectiveness of vaginal DHEA in treating Chinese women with GSM. Therefore, we aim at evaluating the clinical outcome of our participants who have moderate to severe symptoms of GSM who has been treated with vaginal DHEA.
Detailed Description:
Genitourinary syndrome of menopause (GSM) is a common condition with prevalence was up to 80%. \[1\] Symptoms associated with GSM include vaginal or vulvar dryness, itchiness, dyspareunia, increased urinary frequency or urgency and dysuria. \[2\] Although the symptoms are disturbing and causing a significant negative impact on quality of life, it is observed that only a minority of the women receive proper treatment. Treating these GSM-associated symptoms properly is important because these symptoms usually persist with time, unlike vasomotor symptoms of menopause which may subside spontaneously with time.
Current treatments for GSM-associated symptoms in our unit at Department of Obstetrics and Gynaecology, Prince of Wales Hospital include vaginal moisturizer and local estrogen- based medications. For vaginal moisturizer, they usually fail to alter the underlying pathophysiological change in urogenital tract. For estrogen-containing treatment, long term use is not recommended as systemic absorption of hormones may occur. A new medication, vaginal dehydroepiandrosterone (DHEA) has been introduced to our unit to treat women with moderate to severe symptoms of GSM since July 2021. The clinical efficacy and metabolism of vaginal DHEA has been evaluated in western population. There were four randomized placebo- controlled studies \[3-6\] showing that 12 weeks treatment of DHEA improved moderate to severe symptoms of GSM. In comparative studies, the efficacy of DHEA was similar to that of conjugated equine estrogen and estradiol. In addition, due to intracrine action of DHEA in particular tissue, it has not showed to increase the level of circulating estrogen or the androgen level beyond the menopausal range. \[7\]
However, there is lack of local data on the effectiveness of vaginal DHEA in treating Chinese women with GSM. Therefore, we aim at evaluating the clinical outcome of our participants who have moderate to severe symptoms of GSM who has been treated with vaginal DHEA.
All Chinese women who have moderate to severe symptoms of GSM and treated with vaginal DHEA since year 2021-2022. All menopause Chinese women with moderate to severe symptoms of GSM and treated with vaginal DHEA were enrolled for analysis. Menopause is defined as cessation of menses for more than 1 year in women with uterus, or follicle stimulating hormone (FSH) ≥ 40 in women with no menses more than 6 months. Diagnosis of GSM was made after exclusion of other differential diagnosis such as candidiasis / lichen sclerosis/ urodynamic stress incontinence/ detrusor over-activity etc. Moderate to severe symptoms of GSM was defined as a visual analogue score (VAS) of 4 or above of any item including vaginal itchiness, dryness, pain and hotness, dysuria, urinary urgency, stress urinary incontinence, urinary urge incontinence and dyspareunia.
There is a standard dataset for patients presenting with GSM is available in the O\&G Department. During the clinic visit, a thorough history and physical examination including abdominal and genital examination will be performed. A transvaginal ultrasound will be performed to determine the endometrial thickness (ET) and exclude other adnexal pathology. Blood taking for hormonal profile was will be performed for baseline check. Mid-stream urinalysis and high vaginal swab will be taken to rule out any infection. After excluding history of hormonal sensitive cancer, active or history of thromboembolic events, unexplained abnormal uterine bleeding and endometrial thickness ≥5mm. If the participant has moderate to severe symptoms of GSM and fit for vaginal DHEA, a 12-week vaginal DHEA will be prescribed. A follow-up appointment will be given in 3-6 months interval to review symptoms. Participants will receive the intervention of vaginal DHEA as a routine medical care.
The medical records of Chinese participants with moderate to severe symptoms of GSM and treated with vaginal DHEA of the aforesaid period will be reviewed. Participant's demographic data, symptoms severity, clinical assessments, investigations, treatment outcome and adverse effect will be collected. The effect of vaginal DHEA will be studied. The end date to the retrospective data collection is 15 Mar 2022.
Genitourinary syndrome of menopause (GSM) is a prevalent but commonly neglected condition. Symptoms can be disturbing to the affected women and affecting their quality of life. The review of the clinical outcome of Chinese women with moderate to severe symptoms of GSM treated with vaginal DHEA allows us to raise awareness of this condition and improve our clinical management. These could also provide a better local evidence of future clinical, research use and patient care.
Current treatments for GSM-associated symptoms in our unit at Department of Obstetrics and Gynaecology, Prince of Wales Hospital include vaginal moisturizer and local estrogen- based medications. For vaginal moisturizer, they usually fail to alter the underlying pathophysiological change in urogenital tract. For estrogen-containing treatment, long term use is not recommended as systemic absorption of hormones may occur. A new medication, vaginal dehydroepiandrosterone (DHEA) has been introduced to our unit to treat women with moderate to severe symptoms of GSM since July 2021. The clinical efficacy and metabolism of vaginal DHEA has been evaluated in western population. There were four randomized placebo- controlled studies \[3-6\] showing that 12 weeks treatment of DHEA improved moderate to severe symptoms of GSM. In comparative studies, the efficacy of DHEA was similar to that of conjugated equine estrogen and estradiol. In addition, due to intracrine action of DHEA in particular tissue, it has not showed to increase the level of circulating estrogen or the androgen level beyond the menopausal range. \[7\]
However, there is lack of local data on the effectiveness of vaginal DHEA in treating Chinese women with GSM. Therefore, we aim at evaluating the clinical outcome of our participants who have moderate to severe symptoms of GSM who has been treated with vaginal DHEA.
All Chinese women who have moderate to severe symptoms of GSM and treated with vaginal DHEA since year 2021-2022. All menopause Chinese women with moderate to severe symptoms of GSM and treated with vaginal DHEA were enrolled for analysis. Menopause is defined as cessation of menses for more than 1 year in women with uterus, or follicle stimulating hormone (FSH) ≥ 40 in women with no menses more than 6 months. Diagnosis of GSM was made after exclusion of other differential diagnosis such as candidiasis / lichen sclerosis/ urodynamic stress incontinence/ detrusor over-activity etc. Moderate to severe symptoms of GSM was defined as a visual analogue score (VAS) of 4 or above of any item including vaginal itchiness, dryness, pain and hotness, dysuria, urinary urgency, stress urinary incontinence, urinary urge incontinence and dyspareunia.
There is a standard dataset for patients presenting with GSM is available in the O\&G Department. During the clinic visit, a thorough history and physical examination including abdominal and genital examination will be performed. A transvaginal ultrasound will be performed to determine the endometrial thickness (ET) and exclude other adnexal pathology. Blood taking for hormonal profile was will be performed for baseline check. Mid-stream urinalysis and high vaginal swab will be taken to rule out any infection. After excluding history of hormonal sensitive cancer, active or history of thromboembolic events, unexplained abnormal uterine bleeding and endometrial thickness ≥5mm. If the participant has moderate to severe symptoms of GSM and fit for vaginal DHEA, a 12-week vaginal DHEA will be prescribed. A follow-up appointment will be given in 3-6 months interval to review symptoms. Participants will receive the intervention of vaginal DHEA as a routine medical care.
The medical records of Chinese participants with moderate to severe symptoms of GSM and treated with vaginal DHEA of the aforesaid period will be reviewed. Participant's demographic data, symptoms severity, clinical assessments, investigations, treatment outcome and adverse effect will be collected. The effect of vaginal DHEA will be studied. The end date to the retrospective data collection is 15 Mar 2022.
Genitourinary syndrome of menopause (GSM) is a prevalent but commonly neglected condition. Symptoms can be disturbing to the affected women and affecting their quality of life. The review of the clinical outcome of Chinese women with moderate to severe symptoms of GSM treated with vaginal DHEA allows us to raise awareness of this condition and improve our clinical management. These could also provide a better local evidence of future clinical, research use and patient care.
Study Oversight
Has Oversight DMC:
False
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?: