Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027430
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-12-05
Brief Title:
Androgen Replacement Therapy in Women With Hypopituitarism
Sponsor:
Massachusetts General Hospital
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
TheraDerm Administration in Women With Hypopituitarism
Status:
COMPLETED
Status Verified Date:
2001-11
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 is a study to determine whether testosterone replacement with TheraDerm can improve bone density mood sex drive thinking and distribution of body fat and muscle mass in women with hypopituitarism
Detailed Description:
Patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo Group 1 will receive 2 testosterone patches and estrogen pills for 12 months Group 2 will receive 2 placebo patches and estrogen pills for 12 months Changes in bone density bone metabolism markers body composition libido and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-001981-01 | None | None | None |