Trial Outcomes & Findings for CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men (NCT NCT00729859)
NCT ID: NCT00729859
Last Updated: 2012-10-12
Results Overview
Number of CD33 + CD134+ cells as a percentage of all lymphocytes
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline, Day 28
Results posted on
2012-10-12
Participant Flow
Subjects were recruited using rosters from prior research studies, newspaper and online advertisements. Recruitment began December 2008 and ended March 2010.
Before study procedures,2 withdrew consent and 1 was withdrawn by the investigator for missing appointments.4 failed inclusion criteria(1-anemia,1-low testosterone,1-high BMI,1-medications. 31 men enrolled. 22 men completed.
Participant milestones
| Measure |
Group 1: Acyline + Placebo Gel, Placebo Pill
Acyline 300 µg/kg injections Day 0 \& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
|
Group 2: Acyline, Testosterone Gel, Placebo Pill
Acyline 300 µg/kg injections Day 0 \& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
|
Group 3: Acyline, Testosterone Gel, Anastrazole Pill
Acyline 300 μg/kg injections Day 0 \& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Acyline + Placebo Gel, Placebo Pill
Acyline 300 µg/kg injections Day 0 \& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
|
Group 2: Acyline, Testosterone Gel, Placebo Pill
Acyline 300 µg/kg injections Day 0 \& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
|
Group 3: Acyline, Testosterone Gel, Anastrazole Pill
Acyline 300 μg/kg injections Day 0 \& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men
Baseline characteristics by cohort
| Measure |
Group 1: Acyline + Placebo Gel, Placebo Pill
n=8 Participants
Acyline 300 µg/kg injections Day 0 \& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
|
Group 2: Acyline, Testosterone Gel, Placebo Pill
n=8 Participants
Acyline 300 µg/kg injections Day 0 \& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
|
Group 3: Acyline, Testosterone Gel, Anastrazole Pill
n=8 Participants
Acyline 300 μg/kg injections Day 0 \& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
38.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
26.2 kg/m^2
STANDARD_DEVIATION 2.5 • n=5 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 2.1 • n=5 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 3.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28Population: Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed
Number of CD33 + CD134+ cells as a percentage of all lymphocytes
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Endothelial Progenitor Cells
Baseline
|
0.101 percentage of all lymphocytes
Standard Deviation 0.032
|
—
|
—
|
|
Endothelial Progenitor Cells
Day 28
|
0.081 percentage of all lymphocytes
Standard Deviation 0.040
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 28 daysPopulation: Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Follicle Stimulating Hormone (FSH)
Baseline
|
4.2 IU/L
Standard Deviation 2.4
|
2.9 IU/L
Standard Deviation 1.3
|
2.5 IU/L
Standard Deviation 0.9
|
|
Follicle Stimulating Hormone (FSH)
Day 28
|
0.42 IU/L
Standard Deviation 0.7
|
0.39 IU/L
Standard Deviation 0.5
|
0.87 IU/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Luteinizing Hormone Concentration (LH)
Baseline
|
4.3 IU/L
Standard Deviation 2.3
|
4.7 IU/L
Standard Deviation 1.9
|
4.4 IU/L
Standard Deviation 2.2
|
|
Luteinizing Hormone Concentration (LH)
Day 28
|
0.31 IU/L
Standard Deviation 0.2
|
0.69 IU/L
Standard Deviation 1.2
|
1.55 IU/L
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Testosterone Concentration
Baseline testosterone concentration
|
15.4 nmol/L
Standard Deviation 3.4
|
16.3 nmol/L
Standard Deviation 3.3
|
16.5 nmol/L
Standard Deviation 2.6
|
|
Testosterone Concentration
Day 28 testosterone concentration
|
0.8 nmol/L
Standard Deviation 0.8
|
17.8 nmol/L
Standard Deviation 5.5
|
19.0 nmol/L
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Estradiol Concentration
Baseline
|
95.4 pmol/L
Standard Deviation 18.2
|
117.8 pmol/L
Standard Deviation 28.6
|
96.3 pmol/L
Standard Deviation 21.9
|
|
Estradiol Concentration
Day 28
|
31.9 pmol/L
Standard Deviation 11.2
|
109.0 pmol/L
Standard Deviation 28.8
|
36.5 pmol/L
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Sex Hormone Binding Globulin (SHBG)
Baseline
|
34.9 nmol/L
Standard Deviation 17.1
|
23.0 nmol/L
Standard Deviation 10.9
|
27.6 nmol/L
Standard Deviation 6.3
|
|
Sex Hormone Binding Globulin (SHBG)
Day 28
|
37.5 nmol/L
Standard Deviation 16.4
|
22.1 nmol/L
Standard Deviation 10.1
|
25.1 nmol/L
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56Population: per protocol
QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Quantitative Insulin Sensitivity Check Index (QUICKI)
Baseline
|
0.36 QUICKI index
Standard Deviation 0.03
|
0.35 QUICKI index
Standard Deviation 0.02
|
0.36 QUICKI index
Standard Deviation 0.02
|
|
Quantitative Insulin Sensitivity Check Index (QUICKI)
Day 28
|
0.34 QUICKI index
Standard Deviation 0.03
|
0.35 QUICKI index
Standard Deviation 0.02
|
0.38 QUICKI index
Standard Deviation 0.02
|
|
Quantitative Insulin Sensitivity Check Index (QUICKI)
Day 56
|
0.35 QUICKI index
Standard Deviation 0.03
|
0.35 QUICKI index
Standard Deviation 0.02
|
0.36 QUICKI index
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56Population: per protocol
HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Homeostasis Model of Insulin Resistance (HOMA-IR)
Baseline
|
1.8 HOMA score
Standard Deviation 0.9
|
2.0 HOMA score
Standard Deviation 0.9
|
1.6 HOMA score
Standard Deviation 0.6
|
|
Homeostasis Model of Insulin Resistance (HOMA-IR)
Day 28
|
2.4 HOMA score
Standard Deviation 1.0
|
1.9 HOMA score
Standard Deviation 0.9
|
1.4 HOMA score
Standard Deviation 0.8
|
|
Homeostasis Model of Insulin Resistance (HOMA-IR)
Day 56
|
2.2 HOMA score
Standard Deviation 0.9
|
1.9 HOMA score
Standard Deviation 0.9
|
1.7 HOMA score
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56Population: per protocol
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Fasting Serum Insulin
Baseline
|
54 picomolar
Standard Deviation 26
|
65 picomolar
Standard Deviation 28
|
50 picomolar
Standard Deviation 16
|
|
Fasting Serum Insulin
Day 28
|
69 picomolar
Standard Deviation 25
|
59 picomolar
Standard Deviation 26
|
42 picomolar
Standard Deviation 23
|
|
Fasting Serum Insulin
Day 56
|
54 picomolar
Standard Deviation 26
|
64 picomolar
Standard Deviation 27
|
50 picomolar
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 56Population: per protocol
Outcome measures
| Measure |
Group 1: Acyline + Placebo Gel + Placebo Pill
n=8 Participants
Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
|
Group 2: Acyline + T-gel 10g/Day + Placebo Pill
n=6 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and placebo pill for 28 days
|
Group 3: Acyline + T-gel + Oral Anastrozole 1mg
n=8 Participants
Acyline SQ inj. Day 0 \& 14 + T-gel and anastrozole for 28 days
|
|---|---|---|---|
|
Fasting Lipid Levels
Total cholesterol Day 0
|
4.97 mmol/L
Standard Deviation 1.1
|
4.48 mmol/L
Standard Deviation 0.4
|
4.56 mmol/L
Standard Deviation 1.5
|
|
Fasting Lipid Levels
Total cholesterol Day 28
|
5.44 mmol/L
Standard Deviation 1.2
|
4.51 mmol/L
Standard Deviation 0.3
|
4.56 mmol/L
Standard Deviation 0.9
|
|
Fasting Lipid Levels
Total cholesterol Day 56
|
4.95 mmol/L
Standard Deviation 1.1
|
4.14 mmol/L
Standard Deviation 0.6
|
4.27 mmol/L
Standard Deviation 1.2
|
|
Fasting Lipid Levels
LDL choesterol Day 0
|
2.95 mmol/L
Standard Deviation 0.8
|
2.77 mmol/L
Standard Deviation 0.3
|
2.67 mmol/L
Standard Deviation 1.3
|
|
Fasting Lipid Levels
LDL cholesterol Day 28
|
3.29 mmol/L
Standard Deviation 0.7
|
2.80 mmol/L
Standard Deviation 0.2
|
2.75 mmol/L
Standard Deviation 0.8
|
|
Fasting Lipid Levels
LDL cholesterol Day 56
|
2.87 mmol/L
Standard Deviation 0.5
|
2.49 mmol/L
Standard Deviation 0.5
|
2.51 mmol/L
Standard Deviation 1.0
|
|
Fasting Lipid Levels
HDL cholesterol Day 0
|
1.19 mmol/L
Standard Deviation 0.2
|
1.32 mmol/L
Standard Deviation 0.2
|
1.40 mmol/L
Standard Deviation 0.2
|
|
Fasting Lipid Levels
HDL cholesterol Day 28
|
1.37 mmol/L
Standard Deviation 0.2
|
1.32 mmol/L
Standard Deviation 0.1
|
1.32 mmol/L
Standard Deviation 0.2
|
|
Fasting Lipid Levels
HDL cholesterol Day 56
|
1.19 mmol/L
Standard Deviation 0.2
|
1.32 mmol/L
Standard Deviation 0.2
|
1.30 mmol/L
Standard Deviation 0.2
|
|
Fasting Lipid Levels
Triglycerides Day 0
|
1.79 mmol/L
Standard Deviation 2.1
|
0.82 mmol/L
Standard Deviation 0.2
|
1.08 mmol/L
Standard Deviation 0.5
|
|
Fasting Lipid Levels
Triglycerides Day 28
|
1.73 mmol/L
Standard Deviation 1.4
|
0.86 mmol/L
Standard Deviation 0.3
|
1.08 mmol/L
Standard Deviation 0.4
|
|
Fasting Lipid Levels
Triglycerides Day 56
|
1.89 mmol/L
Standard Deviation 2.3
|
0.80 mmol/L
Standard Deviation 0.4
|
1.02 mmol/L
Standard Deviation 0.3
|
Adverse Events
Group 1: Acyline + Placebo Gel, Placebo Pill
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2: Acyline, Testosterone Gel, Placebo Pill
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3: Acyline, Testosterone Gel, Anastrazole Pill
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Acyline + Placebo Gel, Placebo Pill
n=8 participants at risk
Acyline 300 µg/kg injections Day 0 \& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
|
Group 2: Acyline, Testosterone Gel, Placebo Pill
n=6 participants at risk
Acyline 300 µg/kg injections Day 0 \& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
|
Group 3: Acyline, Testosterone Gel, Anastrazole Pill
n=8 participants at risk
Acyline 300 μg/kg injections Day 0 \& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
|
|---|---|---|---|
|
Endocrine disorders
emotional lability, irritability
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
0.00%
0/6 • Dec 2008 - May 2010
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
|
Endocrine disorders
fatigue
|
25.0%
2/8 • Number of events 2 • Dec 2008 - May 2010
|
16.7%
1/6 • Number of events 1 • Dec 2008 - May 2010
|
0.00%
0/8 • Dec 2008 - May 2010
|
|
Endocrine disorders
hot flashes
|
37.5%
3/8 • Number of events 3 • Dec 2008 - May 2010
|
0.00%
0/6 • Dec 2008 - May 2010
|
0.00%
0/8 • Dec 2008 - May 2010
|
|
Skin and subcutaneous tissue disorders
itching at acyline site
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
16.7%
1/6 • Number of events 1 • Dec 2008 - May 2010
|
0.00%
0/8 • Dec 2008 - May 2010
|
|
Endocrine disorders
lightheadedness, clammy
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
0.00%
0/6 • Dec 2008 - May 2010
|
0.00%
0/8 • Dec 2008 - May 2010
|
|
Endocrine disorders
low libido
|
50.0%
4/8 • Number of events 4 • Dec 2008 - May 2010
|
0.00%
0/6 • Dec 2008 - May 2010
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
|
Skin and subcutaneous tissue disorders
skin irritation, gel application site
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
0.00%
0/6 • Dec 2008 - May 2010
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
|
Skin and subcutaneous tissue disorders
itching rash
|
12.5%
1/8 • Number of events 1 • Dec 2008 - May 2010
|
0.00%
0/6 • Dec 2008 - May 2010
|
0.00%
0/8 • Dec 2008 - May 2010
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place