Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611514
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause GSM in Women in Menopause with Previous Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause with Previous Breast Cancer or Currently Under Treatment with Endocrine Therapy for Breast Cancer with Aromatase Inhibitor - LHRHa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPOSE
Brief Summary:
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome GSM due to natural surgical or treatment-induced menopause and the effect on the quality of life including sexual function and mood well-being in women with Breast Cancer A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50 Subjects will be followed up at four weeks and twelve weeks of treatment One and three-month outcomes will be provided after the end of treatment Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None