Trial Outcomes & Findings for ORAL T-6: Oral Androgens in Man-6 (NCT NCT00663793)
NCT ID: NCT00663793
Last Updated: 2011-01-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
14 days
Results posted on
2011-01-24
Participant Flow
Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle WA, between April 2008-March 2009.
19 participants recruited; 19 screened, 2 excluded.
Participant milestones
| Measure |
Testosterone Only
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Testosterone Plus Finasteride
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ORAL T-6: Oral Androgens in Man-6
Baseline characteristics by cohort
| Measure |
Testosterone Only
n=8 Participants
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Testosterone Plus Finasteride
n=8 Participants
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Total
n=16 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
28 kg/m^2
STANDARD_DEVIATION 8 • n=7 Participants
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Estradiol
|
70.1 pmol/L
STANDARD_DEVIATION 16.1 • n=5 Participants
|
114 pmol/L
STANDARD_DEVIATION 54 • n=7 Participants
|
92.0 pmol/L
STANDARD_DEVIATION 35.0 • n=5 Participants
|
|
Height
|
178 centimeters
STANDARD_DEVIATION 5 • n=5 Participants
|
179 centimeters
STANDARD_DEVIATION 7 • n=7 Participants
|
178.5 centimeters
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex Hormone Binding Globulin (SHBG)
|
35.5 nmol/L
STANDARD_DEVIATION 12.8 • n=5 Participants
|
32.5 nmol/L
STANDARD_DEVIATION 19.6 • n=7 Participants
|
34 nmol/L
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Testosterone (T)
|
14.5 nmol/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
16.8 nmol/L
STANDARD_DEVIATION 8.9 • n=7 Participants
|
15.65 nmol/L
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Weight
|
83 kilogram
STANDARD_DEVIATION 18 • n=5 Participants
|
89 kilogram
STANDARD_DEVIATION 22 • n=7 Participants
|
86 kilogram
STANDARD_DEVIATION 20 • n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Testosterone Only
n=8 Participants
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Testosterone Plus Finasteride
n=8 Participants
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
|---|---|---|
|
Area Under the Curve-Serum T
external matrix 'immediate' release
|
143 nmol*h/L
Standard Error 47
|
198 nmol*h/L
Standard Error 86
|
|
Area Under the Curve-Serum T
external matrix 'fast' release
|
144 nmol*h/L
Standard Error 44
|
384 nmol*h/L
Standard Error 273
|
|
Area Under the Curve-Serum T
external matrix 'slow' release
|
162 nmol*h/L
Standard Error 60
|
237 nmol*h/L
Standard Error 141
|
SECONDARY outcome
Timeframe: 14-daysOutcome measures
| Measure |
Testosterone Only
n=8 Participants
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Testosterone Plus Finasteride
n=8 Participants
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
|---|---|---|
|
Area Under the Curve-serum DHT
external matrix 'immediate' release
|
36 nmol*h/L
Standard Error 13
|
23 nmol*h/L
Standard Error 10
|
|
Area Under the Curve-serum DHT
external matrix 'fast' release
|
42 nmol*h/L
Standard Error 21
|
26 nmol*h/L
Standard Error 12
|
|
Area Under the Curve-serum DHT
external matrix 'slow' release
|
39 nmol*h/L
Standard Error 16
|
26 nmol*h/L
Standard Error 11
|
SECONDARY outcome
Timeframe: 14 DaysOutcome measures
| Measure |
Testosterone Only
n=8 Participants
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Testosterone Plus Finasteride
n=8 Participants
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
|---|---|---|
|
Area Under the Curve-E2
external matrix 'immediate' release
|
1812 nmol*h/L
Standard Deviation 405
|
2241 nmol*h/L
Standard Deviation 783
|
|
Area Under the Curve-E2
external matrix 'fast' release
|
1961 nmol*h/L
Standard Deviation 528
|
2002 nmol*h/L
Standard Deviation 861
|
|
Area Under the Curve-E2
external matrix 'slow' release
|
1944 nmol*h/L
Standard Deviation 652
|
3129 nmol*h/L
Standard Deviation 1574
|
Adverse Events
Testosterone Only
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Testosterone Plus Finasteride
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Only
n=8 participants at risk
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
Testosterone Plus Finasteride
n=8 participants at risk
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
|
|---|---|---|
|
Reproductive system and breast disorders
Decreased Libido
|
12.5%
1/8 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Endocrine disorders
Elevated aspartate aminotransferase
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Fatigue
|
0.00%
0/8
|
50.0%
4/8 • Number of events 7
|
|
General disorders
Headache
|
37.5%
3/8 • Number of events 4
|
37.5%
3/8 • Number of events 3
|
|
Endocrine disorders
Hot flashes
|
25.0%
2/8 • Number of events 3
|
50.0%
4/8 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place