Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 7:28 PM
Study NCT ID:
NCT00136695
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2005-08-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anastrozole Administration in Elderly Hypogonadal Men
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Anastrozole Administration in Elderly Hypogonadal Men
Status:
COMPLETED
Status Verified Date:
2022-08
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 purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).
Detailed Description:
It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly useful way to restore normal androgen production in aging men.
This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.
This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01AG025099-05 | NIH | None | https://reporter.nih.gov/quic… | View |
| 1R01AG025099-1A1 | None | None | View |