Trial Outcomes & Findings for Testosterone Plus Finasteride Treatment After Spinal Cord Injury (NCT NCT02248701)
NCT ID: NCT02248701
Last Updated: 2023-09-29
Results Overview
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2023-09-29
Participant Flow
Participants were recruited based on physician referrals at 2 VA medical centers and via community-based advertisements between January 2017 and March 2021 and pre-screened via phone to determine criteria to enroll. Those meeting criteria to enroll were screened for potential eligibility, with the first participant enrolled on April 27, 2017 and the last participant enrolled on December 4, 2020.
Enrolled participants were evaluated at an in-person screening visit to determine if they qualify. Those that did not qualify were excluded from the study before randomization. Of 33 enrolled participants, 12 met inclusion criteria and were randomized to treatment / placebo groups.
Participant milestones
| Measure |
Testosterone Enanthate, Finasteride
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Testosterone Enanthate, Finasteride
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
VA mandated stop on all in person visits for VA sponsored research nationally
|
1
|
0
|
Baseline Characteristics
N=1 participant in the was not analyzed in the testosterone enanthate, finasteride group due to bilateral hip joint replacement present at baseline.
Baseline characteristics by cohort
| Measure |
Testosterone Enanthate, Finasteride
n=7 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 7.8 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
12 participants
n=12 Participants
|
|
Hip bone mineral density
|
0.9788 g/cm^2
STANDARD_DEVIATION 0.2073 • n=6 Participants • N=1 participant in the was not analyzed in the testosterone enanthate, finasteride group due to bilateral hip joint replacement present at baseline.
|
1.016 g/cm^2
STANDARD_DEVIATION 0.1365 • n=5 Participants • N=1 participant in the was not analyzed in the testosterone enanthate, finasteride group due to bilateral hip joint replacement present at baseline.
|
0.996 g/cm^2
STANDARD_DEVIATION 0.1712 • n=11 Participants • N=1 participant in the was not analyzed in the testosterone enanthate, finasteride group due to bilateral hip joint replacement present at baseline.
|
|
Thigh muscle cross-sectional area
|
7483 cm^2
STANDARD_DEVIATION 2096 • n=7 Participants
|
6453 cm^2
STANDARD_DEVIATION 1177 • n=5 Participants
|
7054 cm^2
STANDARD_DEVIATION 1783 • n=12 Participants
|
|
Total body fat
|
30.4 kg
STANDARD_DEVIATION 8.7 • n=6 Participants • Only N=6 analyzed in the testosterone enanthate, finasteride group because data was corrupted at baseline on N=1 participant.
|
30.3 kg
STANDARD_DEVIATION 9.6 • n=5 Participants • Only N=6 analyzed in the testosterone enanthate, finasteride group because data was corrupted at baseline on N=1 participant.
|
30.3 kg
STANDARD_DEVIATION 8.6 • n=11 Participants • Only N=6 analyzed in the testosterone enanthate, finasteride group because data was corrupted at baseline on N=1 participant.
|
|
Walking speed
|
0.90 m/s
STANDARD_DEVIATION 0.33 • n=7 Participants
|
0.76 m/s
STANDARD_DEVIATION 0.35 • n=5 Participants
|
0.84 m/s
STANDARD_DEVIATION 0.33 • n=12 Participants
|
|
Neuromuscular function
|
121 N/m
STANDARD_DEVIATION 37 • n=7 Participants
|
111 N/m
STANDARD_DEVIATION 36 • n=5 Participants
|
117 N/m
STANDARD_DEVIATION 35 • n=12 Participants
|
|
Visceral fat
|
2.85 kg
STANDARD_DEVIATION 1.00 • n=6 Participants • Only N=6 analyzed in the testosterone enanthate, finasteride group because data was corrupted at baseline on N=1 participant.
|
3.19 kg
STANDARD_DEVIATION 1.61 • n=5 Participants • Only N=6 analyzed in the testosterone enanthate, finasteride group because data was corrupted at baseline on N=1 participant.
|
3.00 kg
STANDARD_DEVIATION 1.25 • n=11 Participants • Only N=6 analyzed in the testosterone enanthate, finasteride group because data was corrupted at baseline on N=1 participant.
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only 5 participants in the testosterone enanthate group were evaluated because 1 of 6 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants in the placebo group and 2 additional participants in the testosterone enanthate group had withdrawn from the study and data from 1 participant in the testosterone enanthate group could not be analyzed due to imaging artefact.
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Testosterone Enanthate, Finasteride
n=5 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Percent Change in Hip Bone Mineral Density
Change at 6 months
|
1.7 percent change
Standard Deviation 4.7
|
-0.5 percent change
Standard Deviation 2.4
|
|
Percent Change in Hip Bone Mineral Density
Change at 12 months
|
1.2 percent change
Standard Deviation 7.3
|
1.1 percent change
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only 5 participants in the testosterone enanthate group were evaluated because 2 of 7 with baseline values had withdrawn prior to 6 months. Only 4 participants in the placebo group were evaluated because 1 of 5 with baseline values did not have a follow-up MRI. At 12 months: 1 participant in the placebo group and 2 additional participants in the testosterone enanthate group had withdrawn from the study.
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
Outcome measures
| Measure |
Testosterone Enanthate, Finasteride
n=5 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=4 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Percent Changes in Muscle Cross-Sectional Area
6 months
|
7.9 percent change
Standard Deviation 4.4
|
-0.9 percent change
Standard Deviation 4.1
|
|
Percent Changes in Muscle Cross-Sectional Area
12 months
|
11.4 percent change
Standard Deviation 6.0
|
-1.9 percent change
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only 4 participants in the testosterone enanthate group were evaluated because 2 of 6 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants in the placebo group had withdrawn from the study and 2 additional participants in the testosterone enanthate group had withdrawn from the study.
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Testosterone Enanthate, Finasteride
n=4 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Percent Change in Total Body Fat
6 months
|
-6.8 percent change
Standard Deviation 5.0
|
-4.7 percent change
Standard Deviation 10.6
|
|
Percent Change in Total Body Fat
12 months
|
-8.7 percent change
Standard Deviation 8.4
|
-1.9 percent change
Standard Deviation 9.1
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only 5 participants in the testosterone enanthate group were evaluated because 2 of 7 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants had withdrawn from the placebo group and an additional 2 participants had withdrawn from the testosterone enanthate group.
Absolute change in 10 m walking speed
Outcome measures
| Measure |
Testosterone Enanthate, Finasteride
n=5 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Absolute Change in Walking Speed
6 months
|
0 meters/second (m/s) change
Standard Deviation 0.17
|
0.05 meters/second (m/s) change
Standard Deviation 0.14
|
|
Absolute Change in Walking Speed
12 months
|
0.10 meters/second (m/s) change
Standard Deviation 0.12
|
0.01 meters/second (m/s) change
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only 5 participants in the testosterone enanthate group were evaluated because 2 of 7 with baseline values had withdrawn prior to 6 months. At 6 months: 1 participant in the placebo group and 1 participant in the testosterone enanthate group did not perform testing. At 12 months: 2 participants in the placebo group had withdrawn from the study and 2 additional participant in the testosterone enanthate group had withdrawn from the study.
Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry
Outcome measures
| Measure |
Testosterone Enanthate, Finasteride
n=5 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Percent Change in Neuromuscular Function
6 months
|
19.9 percent change
Standard Deviation 30.7
|
-8.6 percent change
Standard Deviation 14.9
|
|
Percent Change in Neuromuscular Function
12 months
|
15.5 percent change
Standard Deviation 27.0
|
0.5 percent change
Standard Deviation 35.1
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Only 4 participants in the testosterone enanthate group were evaluated because 2 of 6 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants in the placebo group had withdrawn from the study and 2 additional participants in the testosterone enanthate group had withdrawn from the study.
Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Testosterone Enanthate, Finasteride
n=4 Participants
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 Participants
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Percent Change in Visceral Fat
6 months
|
-8.2 percent change
Standard Deviation 17.0
|
-3.2 percent change
Standard Deviation 7.7
|
|
Percent Change in Visceral Fat
12 months
|
-13.6 percent change
Standard Deviation 9.4
|
0.2 percent change
Standard Deviation 11.6
|
Adverse Events
Testosterone Enanthate, Finasteride
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone Enanthate, Finasteride
n=7 participants at risk
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 participants at risk
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
Other adverse events
| Measure |
Testosterone Enanthate, Finasteride
n=7 participants at risk
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Testosterone Enanthate: Subjects receive testosterone (125 mg/week) by intramuscular injection
Finasteride: Subjects receive finasteride (5 mg/day) orally
|
Placebo Treatment
n=5 participants at risk
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Placebo injection: Subjects receive placebo (weekly) by intramuscular injection
Placebo pill: Subjects receive placebo pill (daily) orally
|
|---|---|---|
|
General disorders
aldolase, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
anion gap, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 3 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
alanine aminotransferase (ALT), high
|
28.6%
2/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
aspartate aminotransferase (AST), high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
albumin, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
alkaline phosphatase, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 4 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
calcium, high
|
14.3%
1/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
total cholesterol, high
|
57.1%
4/7 • Number of events 14 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
chloride, low
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
CO2, low
|
28.6%
2/7 • Number of events 7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
creatine phosphokinase (CPK), high
|
14.3%
1/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
creatinine, high
|
28.6%
2/7 • Number of events 3 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
C-reactive protein (CRP), high
|
85.7%
6/7 • Number of events 18 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 9 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
dihydrotestosterone, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
dihydrotestosterone, low
|
71.4%
5/7 • Number of events 13 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 8 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Nervous system disorders
dysarthria
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
edema
|
14.3%
1/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Reproductive system and breast disorders
impaired ejaculation
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
estradiol, high
|
100.0%
7/7 • Number of events 28 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
80.0%
4/5 • Number of events 7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
eosinophils, high
|
71.4%
5/7 • Number of events 22 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
100.0%
5/5 • Number of events 12 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
erythropoietin, high
|
28.6%
2/7 • Number of events 9 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Eye disorders
eye infection
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Psychiatric disorders
depression
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Musculoskeletal and connective tissue disorders
falls
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
glucose, high
|
100.0%
7/7 • Number of events 29 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
100.0%
5/5 • Number of events 23 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
granulocytes, high
|
14.3%
1/7 • Number of events 4 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
80.0%
4/5 • Number of events 12 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
granulocytes, low
|
57.1%
4/7 • Number of events 11 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 8 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
HDL cholesterol, low
|
71.4%
5/7 • Number of events 14 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 13 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
hematocrit, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
hematocrit, low
|
14.3%
1/7 • Number of events 4 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 17 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
hemoglobin, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
hemoglobin, low
|
28.6%
2/7 • Number of events 9 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 15 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
insulin, high
|
28.6%
2/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
80.0%
4/5 • Number of events 20 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
potassium, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
potassium, low
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
LDL cholesterol, high
|
42.9%
3/7 • Number of events 12 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
lymphocytes, high
|
42.9%
3/7 • Number of events 7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 6 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
lymphocytes, low
|
42.9%
3/7 • Number of events 11 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
80.0%
4/5 • Number of events 17 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
mean corpuscular hemoglobin, low
|
28.6%
2/7 • Number of events 7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
mean corpuscular hemoglobin concentration, low
|
42.9%
3/7 • Number of events 8 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
mean corpuscle volume, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
mean corpuscle volume, low
|
14.3%
1/7 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
monocytes, high
|
100.0%
7/7 • Number of events 34 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
100.0%
5/5 • Number of events 23 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
mean platelet volume, high
|
57.1%
4/7 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
myelocytes, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
42.9%
3/7 • Number of events 4 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Ear and labyrinth disorders
otitis media
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Nervous system disorders
paresthesia
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Reproductive system and breast disorders
penile shrinkage
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
total protein, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
prostate-specific antigen (PSA), high
|
28.6%
2/7 • Number of events 3 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
prostate induration
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
red blood cell count, low
|
28.6%
2/7 • Number of events 3 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 12 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
red blood cell distribution width, high
|
42.9%
3/7 • Number of events 9 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
red blood cell distribution width, low
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 6 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
segmented neurtrophils, low
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
sex-hormone binding globulin (SHBG), high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 3 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
sex-hormone binding globulin (SHBG), low
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
sodium, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Reproductive system and breast disorders
testicular size reduced
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
testosterone, high
|
71.4%
5/7 • Number of events 12 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
testosterone, low
|
28.6%
2/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Investigations
triglycerides, high
|
57.1%
4/7 • Number of events 11 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
60.0%
3/5 • Number of events 17 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
urea nitrogen, high
|
0.00%
0/7 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
40.0%
2/5 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
urea nitrogen, low
|
28.6%
2/7 • Number of events 4 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
urobilinogen, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
Renal and urinary disorders
urinary tract infection
|
14.3%
1/7 • Number of events 2 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
white blood cell count, high
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
20.0%
1/5 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
|
General disorders
white blood cell count, low
|
14.3%
1/7 • Number of events 1 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
0.00%
0/5 • 12 months
Data on adverse events were assessed at regular study visits and via weekly phone assessments with all study participants.
|
Additional Information
Joshua Yarrow, MS, PhD
North Florida/South Georgia Veterans Health System
Phone: (352) 548-6477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place