Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737329
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-28
First Post:
2023-02-10
Brief Title:
Efficacy Safety and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency
Sponsor:
Federal State Budget Institution Research Center for Obstetrics Gynecology and Perinatology Ministry of Healthcare
Organization:
Federal State Budget Institution Research Center for Obstetrics Gynecology and Perinatology Ministry of Healthcare
Study Overview
Official Title:
Optimization of Management Tactics for Women With Premature Ovarian Insufficiency Taking Into Account Their Clinical and Hormonal Profile
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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 goal of this study is to assess the effects of higher doses versus standard hormone therapy on quality of life QoL symptoms due to estrogen deficiency and bone health in women with premature ovarian insufficiency POI
The efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of Estradiol E2 Follicle-Stimulating Hormone FSH Luteinizing hormone LH total Testosterone T Estrone E1 E1 sulfate E1S and Sex Hormone Binding Globulin SHBG Bone mineral density BMD will be measured using dual-energy X-ray absorptiometry Safety will be assessed by measuring endometrial thickness with Gynecological transvaginal ultrasound TVS treatment-related adverse events AEs and treatment-emergent AEs monitoring
The efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of Estradiol E2 Follicle-Stimulating Hormone FSH Luteinizing hormone LH total Testosterone T Estrone E1 E1 sulfate E1S and Sex Hormone Binding Globulin SHBG Bone mineral density BMD will be measured using dual-energy X-ray absorptiometry Safety will be assessed by measuring endometrial thickness with Gynecological transvaginal ultrasound TVS treatment-related adverse events AEs and treatment-emergent AEs monitoring
Detailed Description:
None
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