Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535323
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2020-08-26
Brief Title:
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Single Arm Prospective Study to Evaluate the Treatment of Genitourinary Syndrome of Menopause With Platelet Rich Plasma PRP in Women With a History of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
This phase I trial is to find out possible benefits andor side effects of platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer Platelet rich plasma is produced by collecting approximately 60-90 ml 4-6 tablespoons of blood from the vein in patients arm The blood is spun using a centrifuge that separates the plasma and red blood cells This allows doctors to collect the platelet rich plasma that is then loaded into individual sterile syringes for injection Giving platelet rich plasma may help relief symptoms of genitourinary syndrome of menopause in patients with breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety and feasibility of use of platelet rich plasma PRP treatment in breast cancer survivors with genitourinary syndrome of menopause GSM
SECONDARY OBJECTIVE
I To determine the preliminary efficacy in treatment of vaginal atrophy urinary symptoms assessment of sexual function quality of life symptoms and patient global impression of improvement and tolerability
OUTLINE
Patients receive platelet rich plasma via injection into the vaginal area
After completion of study treatment patients are followed up for 6 months
I To determine the safety and feasibility of use of platelet rich plasma PRP treatment in breast cancer survivors with genitourinary syndrome of menopause GSM
SECONDARY OBJECTIVE
I To determine the preliminary efficacy in treatment of vaginal atrophy urinary symptoms assessment of sexual function quality of life symptoms and patient global impression of improvement and tolerability
OUTLINE
Patients receive platelet rich plasma via injection into the vaginal area
After completion of study treatment patients are followed up for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-02777 | REGISTRY | CTRP Clinical Trial Reporting Program | None |