Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00095212
Status:
COMPLETED
Last Update Posted:
2010-04-14
First Post:
2004-11-01
Brief Title:
Androgen Effects in HIV-infected Women
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Androgen Effects in HIV-infected Women
Status:
COMPLETED
Status Verified Date:
2010-04
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:
Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density The effects of long-term androgen therapy on lean body mass bone density and other clinical endpoints including quality of life functional status and neurocognitive function in HIV-infected women are not known
Detailed Description:
We will perform an 18-month randomized double-blinded placebo-controlled study among relatively androgen deficient women with HIV to determine the effects of testosterone administration on lean body mass The administered dose will be 300 micrograms twice a week vs identical placebo in the form of a transdermal preparation Secondary endpoints include effects on bone density quality of life neurocognitive function and menstrual function Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study Assuming a 15 dropout rate and 25 randomized patients the probability is 80 percent that the study will detect a treatment difference at a two sided 5000 percent significance level if the true difference between the treatments is 27 kg This is based on the assumption that the standard deviation of the response variable lean body mass by DEXA is 23 kg as was shown by Choi et al1 over 12 weeks in HIV-infected women at the same dose of 300 ug 2xweek
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 |
|---|---|---|---|
| R01DK054167 | NIH | None | httpsreporternihgovquickSearchR01DK054167 |