Trial Outcomes & Findings for Anastrozole Administration in Elderly Hypogonadal Men (NCT NCT00136695)
NCT ID: NCT00136695
Last Updated: 2022-09-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Baseline and 1 year
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Anastrozole
anastrozole
anastrozole: 1 mg QD
|
Placebo
placebo
anastrozole: 1 mg QD
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anastrozole Administration in Elderly Hypogonadal Men
Baseline characteristics by cohort
| Measure |
Anastrozole
n=34 Participants
anastrozole
anastrozole: 1 mg QD
|
Placebo
n=35 Participants
placebo
anastrozole: 1 mg QD
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 4 • n=5 Participants
|
66 years
STANDARD_DEVIATION 4 • n=7 Participants
|
66 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 yearOutcome measures
| Measure |
Anastrozole
n=34 Participants
anastrozole
anastrozole: 1 mg QD
|
Placebo
n=35 Participants
placebo
anastrozole: 1 mg QD
|
|---|---|---|
|
Change in Lean Body Mass
|
-2000 grams
Standard Deviation 1000
|
-1500 grams
Standard Deviation 500
|
Adverse Events
Anastrozole
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anastrozole
n=34 participants at risk
anastrozole
anastrozole: 1 mg QD
|
Placebo
n=35 participants at risk
placebo
anastrozole: 1 mg QD
|
|---|---|---|
|
Renal and urinary disorders
prostate cancer
|
0.00%
0/34
|
2.9%
1/35
|
|
Endocrine disorders
pancreatic cancer
|
2.9%
1/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
hepatitis A
|
2.9%
1/34
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
pulmonary embolism
|
2.9%
1/34
|
0.00%
0/35
|
|
Cardiac disorders
embolic stroke
|
2.9%
1/34
|
0.00%
0/35
|
Other adverse events
| Measure |
Anastrozole
n=34 participants at risk
anastrozole
anastrozole: 1 mg QD
|
Placebo
n=35 participants at risk
placebo
anastrozole: 1 mg QD
|
|---|---|---|
|
Renal and urinary disorders
PSA increase
|
8.8%
3/34
|
8.6%
3/35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place