Hypogonadism
Conditions
Keywords
Aging
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.
Interventions
DRUGanastrozole
1 mg QD
Sponsors
National Institute on Aging (NIA)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men ages 60 and older * Serum testosterone between 150-300 ng/dL * Symptoms suggestive of androgen deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Lean Body Mass | Baseline and 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anastrozole anastrozole
anastrozole: 1 mg QD | 34 |
| Placebo placebo
anastrozole: 1 mg QD | 35 |
| Total | 69 |
Baseline characteristics
| Characteristic | Anastrozole | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 4 | 66 years STANDARD_DEVIATION 4 | 66 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 34 Participants | 35 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 34 | 3 / 35 |
| serious Total, serious adverse events | 4 / 34 | 1 / 35 |
Outcome results
Primary
Change in Lean Body Mass
Time frame: Baseline and 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anastrozole | Change in Lean Body Mass | -2000 grams | Standard Deviation 1000 |
| Placebo | Change in Lean Body Mass | -1500 grams | Standard Deviation 500 |