Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004400
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal HIV-Positive Women
Sponsor:
Charles Drew University of Medicine and Science
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-05
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:
OBJECTIVES I Determine whether physiologic testosterone replacement can increase fat-free mass therefore contributing to weight maintenance improved muscle function and quality of life in HIV-infected women
II Examine the mechanism of testosterone-induced increase in fat-free mass
II Examine the mechanism of testosterone-induced increase in fat-free mass
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study Patients are randomized to one of three arms
Arm I Patients receive two placebo transdermal patches applied twice a week every 3-4 days
Arm II Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week every 3-4 days
Arm III Patients receive two testosterone transdermal patches applied twice a week every 3-4 days
Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration Patients are followed on day 1 every 2 weeks during treatment and at the end of the recovery period Quality of life is assessed before treatment begins and at weeks 6 and 12
Completion date provided represents the completion date of the grant per OOPD records
Arm I Patients receive two placebo transdermal patches applied twice a week every 3-4 days
Arm II Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week every 3-4 days
Arm III Patients receive two testosterone transdermal patches applied twice a week every 3-4 days
Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration Patients are followed on day 1 every 2 weeks during treatment and at the end of the recovery period Quality of life is assessed before treatment begins and at weeks 6 and 12
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDUMS-FDR001397 | None | None | None |