Trial Outcomes & Findings for Metabolic Effects of Androgenicity in Aging Men and Women (NCT NCT00680797)
NCT ID: NCT00680797
Last Updated: 2017-06-15
Results Overview
As measured by change in insulin levels pre- and post-hormone changes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-06-15
Participant Flow
Recruitment methods included flyers and advertisement in local newspapers. Healthy Veteran and community participants who responded to to advertisement were screened by telephone for exclusion criteria. If no exclusion criteria were reported, participants were scheduled for a screening history and physical.
Participant milestones
| Measure |
+T +E
+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch
|
+T -E
+Testosterone, -Estrogen
Testosterone: Testosterone gel
|
-T +E
-Testosterone, +Estrogen
Estrogen: Estrogen patch
|
-T -E
-Testosterone, -Estrogen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Effects of Androgenicity in Aging Men and Women
Baseline characteristics by cohort
| Measure |
+T +E
n=9 Participants
+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch
|
+T -E
n=8 Participants
+Testosterone, -Estrogen
Testosterone: Testosterone gel
|
-T +E
n=8 Participants
-Testosterone, +Estrogen
Estrogen: Estrogen patch
|
-T -E
n=8 Participants
-Testosterone, -Estrogen
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 8 • n=99 Participants
|
66 years
STANDARD_DEVIATION 5 • n=107 Participants
|
69 years
STANDARD_DEVIATION 6 • n=206 Participants
|
63 years
STANDARD_DEVIATION 3 • n=7 Participants
|
66 years
STANDARD_DEVIATION 6 • n=31 Participants
|
|
Sex/Gender, Customized
Male
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
8 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
8 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
Body-Mass-Index
|
27.1 kilogram/meter squared
STANDARD_DEVIATION 4.9 • n=99 Participants
|
28.6 kilogram/meter squared
STANDARD_DEVIATION 4.3 • n=107 Participants
|
28.2 kilogram/meter squared
STANDARD_DEVIATION 4.1 • n=206 Participants
|
29.0 kilogram/meter squared
STANDARD_DEVIATION 2.9 • n=7 Participants
|
28.2 kilogram/meter squared
STANDARD_DEVIATION 4 • n=31 Participants
|
|
Total testosterone
|
419.6 nanogram/deciliter
STANDARD_DEVIATION 146.5 • n=99 Participants
|
418.9 nanogram/deciliter
STANDARD_DEVIATION 207.7 • n=107 Participants
|
480.0 nanogram/deciliter
STANDARD_DEVIATION 231.7 • n=206 Participants
|
558.3 nanogram/deciliter
STANDARD_DEVIATION 362.9 • n=7 Participants
|
467.7 nanogram/deciliter
STANDARD_DEVIATION 242 • n=31 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Two participants had missing values post-intervention therefore number of participants analyzed total 31.
As measured by change in insulin levels pre- and post-hormone changes
Outcome measures
| Measure |
+T +E
n=8 Participants
+Testosterone, +Estrogen
Testosterone: Testosterone gel
Estrogen: Estrogen patch
|
+T -E
n=8 Participants
+Testosterone, -Estrogen
Testosterone: Testosterone gel
|
-T +E
n=8 Participants
-Testosterone, +Estrogen
Estrogen: Estrogen patch
|
-T -E
n=7 Participants
-Testosterone, -Estrogen
|
|---|---|---|---|---|
|
Insulin Sensitivity
|
-0.16 micro International Units/mL
Standard Deviation 10.8
|
2.62 micro International Units/mL
Standard Deviation 5.47
|
-0.50 micro International Units/mL
Standard Deviation 2.54
|
1.83 micro International Units/mL
Standard Deviation 4.24
|
Adverse Events
+T +E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
+T -E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
-T +E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
-T -E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place