Trial Outcomes & Findings for ITT4 Intratesticular Hormonal Milieu in Man (ITT4) (NCT NCT01215292)
NCT ID: NCT01215292
Last Updated: 2014-03-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
10 days
Results posted on
2014-03-31
Participant Flow
Healthy men, aged 18-50 years were recruited for this study using newspaper and online advertisement, including flyers posted at the University of Washington, Seattle.
Fifty-two men were screened for the study and 46 met all inclusion criteria. Six subjects withdrew from the study prior to any procedures and 40 were randomized (n=8/group. Exclusion criteria included liver disease or adrenal insufficiency, Body Mass Index \> 32, abnormal test results, skin conditions for gel, alcohol/drug abuse etc.
Participant milestones
| Measure |
Acyline & T Gel & Ketoconazole 400
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Dutasteride
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Placebo Ketoconazole
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
|
Acyline & T Gel & Ketoconazole 800
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
|
Group 5: Anastrazole
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
Baseline characteristics by cohort
| Measure |
Acyline & T Gel & Ketoconazole 400
n=8 Participants
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Dutasteride
n=8 Participants
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Placebo Ketoconazole
n=8 Participants
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
|
Acyline & T Gel & Ketoconazole 800
n=8 Participants
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
|
Group 5: Anastrazole
n=8 Participants
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
22.5 years
n=5 Participants
|
21.5 years
n=7 Participants
|
24 years
n=5 Participants
|
22 years
n=4 Participants
|
21.5 years
n=21 Participants
|
22 years
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
40 participants
n=8 Participants
|
|
Serum FSH
|
2.3 IU/L
n=5 Participants
|
2.7 IU/L
n=7 Participants
|
2.7 IU/L
n=5 Participants
|
2.4 IU/L
n=4 Participants
|
2.3 IU/L
n=21 Participants
|
2.6 IU/L
n=8 Participants
|
|
Serum Testosterone
|
5.5 ng/mL
n=5 Participants
|
5.4 ng/mL
n=7 Participants
|
5.2 ng/mL
n=5 Participants
|
5.3 ng/mL
n=4 Participants
|
5.2 ng/mL
n=21 Participants
|
5.3 ng/mL
n=8 Participants
|
|
Serum DHT
|
0.44 ng/mL
n=5 Participants
|
0.5 ng/mL
n=7 Participants
|
0.5 ng/mL
n=5 Participants
|
0.44 ng/mL
n=4 Participants
|
0.42 ng/mL
n=21 Participants
|
0.46 ng/mL
n=8 Participants
|
|
Serum E2
|
39 pg/mL
n=5 Participants
|
24 pg/mL
n=7 Participants
|
28.3 pg/mL
n=5 Participants
|
39 pg/mL
n=4 Participants
|
39.4 pg/mL
n=21 Participants
|
28.3 pg/mL
n=8 Participants
|
|
Serum ADD
|
0.7 ng/mL
n=5 Participants
|
0.75 ng/mL
n=7 Participants
|
0.76 ng/mL
n=5 Participants
|
0.69 ng/mL
n=4 Participants
|
0.65 ng/mL
n=21 Participants
|
0.67 ng/mL
n=8 Participants
|
|
Serum DHEA
|
3.9 ng/mL
n=5 Participants
|
3.9 ng/mL
n=7 Participants
|
4.2 ng/mL
n=5 Participants
|
4.6 ng/mL
n=4 Participants
|
3.8 ng/mL
n=21 Participants
|
3.9 ng/mL
n=8 Participants
|
|
Serum 17-OHP
|
6 ng/mL
n=5 Participants
|
6.1 ng/mL
n=7 Participants
|
7.2 ng/mL
n=5 Participants
|
4.8 ng/mL
n=4 Participants
|
6 ng/mL
n=21 Participants
|
6.1 ng/mL
n=8 Participants
|
|
Serum LH
|
5 IU/L
n=5 Participants
|
4.7 IU/L
n=7 Participants
|
4.3 IU/L
n=5 Participants
|
5.8 IU/L
n=4 Participants
|
4.9 IU/L
n=21 Participants
|
4.8 IU/L
n=8 Participants
|
PRIMARY outcome
Timeframe: 10 daysOutcome measures
| Measure |
Acyline + Testosterone Gel + Placebo
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + placebo
|
Acyline + Tgel + Ketoconazole 400mg
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
|
Acyline + Tgel + Ketoconazole 800mg
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
|
Acyline & TGel & Dutasteride 2.5mg
n=8 Participants
|
Acyline & TGel & Anastrazole 1mg
n=8 Participants
|
|---|---|---|---|---|---|
|
Intratesticular Testosterone (IT-T) Level
|
14 ng/mL
Interval 8.0 to 21.2
|
3.7 ng/mL
Interval 2.6 to 7.2
|
1.7 ng/mL
Interval 0.9 to 4.0
|
18.4 ng/mL
Interval 15.3 to 24.8
|
24.0 ng/mL
Interval 17.7 to 42.0
|
PRIMARY outcome
Timeframe: 10 daysOutcome measures
| Measure |
Acyline + Testosterone Gel + Placebo
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + placebo
|
Acyline + Tgel + Ketoconazole 400mg
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
|
Acyline + Tgel + Ketoconazole 800mg
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
|
Acyline & TGel & Dutasteride 2.5mg
n=8 Participants
|
Acyline & TGel & Anastrazole 1mg
n=8 Participants
|
|---|---|---|---|---|---|
|
Intratesticular Dihydrotestosterone (DHT) Level
|
3.17 ng/mL
Interval 2.18 to 3.9
|
2.08 ng/mL
Interval 1.55 to 2.35
|
1.46 ng/mL
Interval 0.75 to 2.25
|
0.12 ng/mL
Interval 0.09 to 0.15
|
3.63 ng/mL
Interval 1.47 to 4.16
|
PRIMARY outcome
Timeframe: 10 daysOutcome measures
| Measure |
Acyline + Testosterone Gel + Placebo
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + placebo
|
Acyline + Tgel + Ketoconazole 400mg
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
|
Acyline + Tgel + Ketoconazole 800mg
n=8 Participants
300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
|
Acyline & TGel & Dutasteride 2.5mg
n=8 Participants
|
Acyline & TGel & Anastrazole 1mg
n=8 Participants
|
|---|---|---|---|---|---|
|
Intratesticular Androstenedione (ADD) Level
|
.87 ng/mL
Interval 0.67 to 2.1
|
0.5 ng/mL
Interval 0.3 to 0.7
|
0.12 ng/mL
Interval 0.1 to 0.5
|
1.7 ng/mL
Interval 1.14 to 3.0
|
3.6 ng/mL
Interval 1.6 to 11.9
|
Adverse Events
Acyline & T Gel & Ketoconazole 400
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Acyline & T Gel & Dutasteride
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Acyline & T Gel & Placebo Ketoconazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Acyline & T Gel & Ketoconazole 800
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 5: Anastrazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acyline & T Gel & Ketoconazole 400
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Dutasteride
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Placebo Ketoconazole
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
|
Acyline & T Gel & Ketoconazole 800
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
|
Group 5: Anastrazole
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
|
|---|---|---|---|---|---|
|
Endocrine disorders
Testicular hematoma and hematocele
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
Other adverse events
| Measure |
Acyline & T Gel & Ketoconazole 400
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Dutasteride
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
|
Acyline & T Gel & Placebo Ketoconazole
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
|
Acyline & T Gel & Ketoconazole 800
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
|
Group 5: Anastrazole
n=8 participants at risk
Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
abdomenal ecchymosis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Psychiatric disorders
Change in mood/irritability
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Endocrine disorders
Decreased libido
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Finger laceration
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
37.5%
3/8 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
|
Endocrine disorders
Pain at spermatic cord/at scrotum
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Immune system disorders
platar fascitis
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Endocrine disorders
Prostatitis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergies
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
pruritus/rash
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place