Anastrozole Administration in Elderly Hypogonadal Men

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Mass General Brigham

Status and phase

Completed
Phase 2

Conditions

Hypogonadism

Treatments

Drug: anastrozole

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00136695
AG0035
5R01AG025099-05 (U.S. NIH Grant/Contract)
1R01AG025099-1A1

Details and patient eligibility

About

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).

Full 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.

Enrollment

88 patients

Sex

Male

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Men ages 60 and older
  • Serum testosterone between 150-300 ng/dL
  • Symptoms suggestive of androgen deficiency

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

88 participants in 2 patient groups, including a placebo group

anastrozole
Experimental group
Description:
anastrozole
Treatment:
Drug: anastrozole
placebo
Placebo Comparator group
Description:
placebo
Treatment:
Drug: anastrozole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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