Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425978
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Efficacy of the Use of Cellular Matrix A-CP-HA Kit
Sponsor:
Fundación Santiago Dexeus Font
Organization:
Institut Universitari Dexeus
Study Overview
Official Title:
The Efficacy of the Use of Cellular Matrix A-CP-HA Kit Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid Compared to Local Estrogen Therapy Blissel Estriol 50 Microgramsg Vaginal Gel in Women With Genitourinary Syndrome of Menopause A Randomized Controlled Trial With a Second Blind Observer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
CellularMatrix
Brief Summary:
This study is a randomized controlled non-inferiority trial that will be performed on 192 women on Menopause absence of menstruation for at least 12 months with diagnostic of genitourinary syndrome of menopause SGM and a vaginal health index 15 points that are sexually active
Patients will be randomized 11 equal number assigned to each of the two treatment groups to receive treatment with two dose of Cellular Matrix A-CP-HA Kit a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid separated for a month and control group that will receive the standard treatment for SGM local estrogen therapy Blissel estriol 50 microgramsg vaginal gel
Both groups will be follow-up for 3 and 6 month afther treatment a blind observer will assess the application of the validated scale VHIS VHI and the investigators will do the FSD symptom record maturation index follow-up photography and evaluation of adverse events and treatment compliance and adherence
Patients will be randomized 11 equal number assigned to each of the two treatment groups to receive treatment with two dose of Cellular Matrix A-CP-HA Kit a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid separated for a month and control group that will receive the standard treatment for SGM local estrogen therapy Blissel estriol 50 microgramsg vaginal gel
Both groups will be follow-up for 3 and 6 month afther treatment a blind observer will assess the application of the validated scale VHIS VHI and the investigators will do the FSD symptom record maturation index follow-up photography and evaluation of adverse events and treatment compliance and adherence
Detailed Description:
This study is a randomized controlled non-inferiority trial with a second blind observer comparing effectiveness of the use of Cellular Matrix A-CP-HA Kit a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid to the standard line of treatment local estrogen therapy Blissel estriol 50 microgramsg vaginal gel in women with genitourinary syndrome of menopause SGM Duration of the study estimated is 24 months
A total of 192 menopausal women with absence of menstruation for at least 12 months 70 years old that are sexually active and who report symptoms and signs of SGM with a vaginal health index 15 points Patients will be excluded if are in treatment with systemic or local hormonal treatment in the last 3 months Tamoxifen or Aromatase inhibitor treatments Vulvovaginal pathologies condyloma vaginal intraepithelial neoplasia vaginal carcinoma lichen sclerosus lichen planus history of radiation history of cervical cancer other gynecologic cancer or pelvic radiation or active genital infection eg g bacterial vaginosis genital herpes candida Contraindication for vaginal estrogen therapy Women with thrombocytopenia or coagulation disorders systemic infections STDs cancer of any type in recent treatment connective tissue diseases Women who have had pelvic surgery within 6 months
Patients will be randomized 11 equal number assigned to each of the two treatment groups to receive treatment with two dose of Cellular Matrix A-CP-HA Kit a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid separated for a month and control group that will receive the standard treatment for SGM local estrogen therapy Blissel estriol 50 microgramsg vaginal gel
Patients will interviewed about their medical history age of menopause symptoms related and history of treatments Evaluation of the Vaginal Health Index VHIS Vulvar Health Index VHI vaginal pH and vaginal maturation index vaginal cytology The intensity of VVA symptoms vaginal burning vaginal itching vaginal dryness dyspareunia and dysuria will be measured using a 5-cm visual analog scale VAS and a valuation of Female Sexual Distress FSD score Photographic monitoring during all phases of the procedure Routine laboratory test serology will requested for both groups valid up to 3 months
Both groups will be follow-up for 3 and 6 month afther treatment a blind observer will assess the application of the validated scale VHIS VHI and the investigators will do the FSD symptom record maturation index follow-up photography and evaluation of adverse events and treatment compliance and adherence
A total of 192 menopausal women with absence of menstruation for at least 12 months 70 years old that are sexually active and who report symptoms and signs of SGM with a vaginal health index 15 points Patients will be excluded if are in treatment with systemic or local hormonal treatment in the last 3 months Tamoxifen or Aromatase inhibitor treatments Vulvovaginal pathologies condyloma vaginal intraepithelial neoplasia vaginal carcinoma lichen sclerosus lichen planus history of radiation history of cervical cancer other gynecologic cancer or pelvic radiation or active genital infection eg g bacterial vaginosis genital herpes candida Contraindication for vaginal estrogen therapy Women with thrombocytopenia or coagulation disorders systemic infections STDs cancer of any type in recent treatment connective tissue diseases Women who have had pelvic surgery within 6 months
Patients will be randomized 11 equal number assigned to each of the two treatment groups to receive treatment with two dose of Cellular Matrix A-CP-HA Kit a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid separated for a month and control group that will receive the standard treatment for SGM local estrogen therapy Blissel estriol 50 microgramsg vaginal gel
Patients will interviewed about their medical history age of menopause symptoms related and history of treatments Evaluation of the Vaginal Health Index VHIS Vulvar Health Index VHI vaginal pH and vaginal maturation index vaginal cytology The intensity of VVA symptoms vaginal burning vaginal itching vaginal dryness dyspareunia and dysuria will be measured using a 5-cm visual analog scale VAS and a valuation of Female Sexual Distress FSD score Photographic monitoring during all phases of the procedure Routine laboratory test serology will requested for both groups valid up to 3 months
Both groups will be follow-up for 3 and 6 month afther treatment a blind observer will assess the application of the validated scale VHIS VHI and the investigators will do the FSD symptom record maturation index follow-up photography and evaluation of adverse events and treatment compliance and adherence
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507200-31-00 | CTIS | None | None |