Trial Outcomes & Findings for HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (NCT NCT00839319)
NCT ID: NCT00839319
Last Updated: 2016-01-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
10 days
Results posted on
2016-01-11
Participant Flow
Subjects were recruited using rosters from prior research studies and newspaper and online advertisements.
2 of 61 men decided not to enroll. 19 failed inclusion criteria, 1 withdrew consent before study procedures, 1 dropped out after Day 1, and 1 was withdrawn by the investigator for syncopal reaction. 6 did not suppress serum luteinizing hormone(affecting intratesticular testosterone)and were excluded from analysis. 31 completed the study.
Participant milestones
| Measure |
Acyline Plus Placebo
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
7
|
5
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone
Baseline characteristics by cohort
| Measure |
Acyline Plus Placebo
n=6 Participants
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
n=7 Participants
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
n=8 Participants
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Serum 17-Hydroxyprogesterone
|
4.7 nmol/L
n=5 Participants
|
4.9 nmol/L
n=7 Participants
|
5.9 nmol/L
n=5 Participants
|
4.3 nmol/L
n=4 Participants
|
4.6 nmol/L
n=21 Participants
|
4.9 nmol/L
n=8 Participants
|
|
Intratesticular Testosterone (ITT-T)
|
3467 nmol/L
n=5 Participants
|
2425 nmol/L
n=7 Participants
|
1821 nmol/L
n=5 Participants
|
3502 nmol/L
n=4 Participants
|
2933 nmol/L
n=21 Participants
|
2508 nmol/L
n=8 Participants
|
|
Age, Customized
|
21 years
n=5 Participants
|
25 years
n=7 Participants
|
22 years
n=5 Participants
|
22 years
n=4 Participants
|
22 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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
24.8 kg/m^2
n=5 Participants
|
24.1 kg/m^2
n=7 Participants
|
24.9 kg/m^2
n=5 Participants
|
25.8 kg/m^2
n=4 Participants
|
23.7 kg/m^2
n=21 Participants
|
24.1 kg/m^2
n=8 Participants
|
|
Serum Luteinizing Hormone (LH)
|
3.5 IU/L
n=5 Participants
|
3.0 IU/L
n=7 Participants
|
3.4 IU/L
n=5 Participants
|
2.9 IU/L
n=4 Participants
|
3.8 IU/L
n=21 Participants
|
3.4 IU/L
n=8 Participants
|
|
Serum Follicle Simulating Hormone (FSH)
|
2.7 IU/L
n=5 Participants
|
2.4 IU/L
n=7 Participants
|
2.6 IU/L
n=5 Participants
|
2.2 IU/L
n=4 Participants
|
1.9 IU/L
n=21 Participants
|
2.4 IU/L
n=8 Participants
|
|
Serum Testosterone (T)
|
13.0 nmol/L
n=5 Participants
|
15.0 nmol/L
n=7 Participants
|
14.2 nmol/L
n=5 Participants
|
16.8 nmol/L
n=4 Participants
|
15.0 nmol/L
n=21 Participants
|
14.6 nmol/L
n=8 Participants
|
|
Serum Dihydrotestosterone (DHT)
|
1.0 nmol/L
n=5 Participants
|
1.3 nmol/L
n=7 Participants
|
1.2 nmol/L
n=5 Participants
|
0.9 nmol/L
n=4 Participants
|
1.1 nmol/L
n=21 Participants
|
1.1 nmol/L
n=8 Participants
|
|
Serum Estradiol
|
89 pmol/L
n=5 Participants
|
65 pmol/L
n=7 Participants
|
62 pmol/L
n=5 Participants
|
77 pmol/L
n=4 Participants
|
86 pmol/L
n=21 Participants
|
77 pmol/L
n=8 Participants
|
|
Intratesticular Dihydrotestosterone (ITT-DHT)
|
18.0 nmol/L
n=5 Participants
|
5.0 nmol/L
n=7 Participants
|
7.6 nmol/L
n=5 Participants
|
18.8 nmol/L
n=4 Participants
|
12.9 nmol/L
n=21 Participants
|
11.9 nmol/L
n=8 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Analysis per protocol. Due to nonnormality, the data were expressed as medians and 25th and 75 percentiles. Analysis of both baseline and end of treatment hormone concentrations performed on 31 subjects who completed all study procedures and who suppressed serum LH below the lower limit of normal at end of treatment.
Outcome measures
| Measure |
Acyline Plus Placebo
n=6 Participants
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
n=7 Participants
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
n=8 Participants
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
|---|---|---|---|---|---|
|
Serum Testosterone (T)
|
0.43 nmol/liter
Interval 0.35 to 0.76
|
1.5 nmol/liter
Interval 0.79 to 4.9
|
3.7 nmol/liter
Interval 1.0 to 8.5
|
8.4 nmol/liter
Interval 4.9 to 11.0
|
16 nmol/liter
Interval 13.0 to 20.0
|
PRIMARY outcome
Timeframe: 10 daysOutcome measures
| Measure |
Acyline Plus Placebo
n=6 Participants
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
n=7 Participants
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
n=8 Participants
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
|---|---|---|---|---|---|
|
Serum Luteinizing Hormone (LH)
|
0.13 IU/L
Interval 0.07 to 0.23
|
0.28 IU/L
Interval 0.2 to 1.63
|
0.49 IU/L
Interval 0.16 to 1.3
|
0.39 IU/L
Interval 0.28 to 1.7
|
0.14 IU/L
Interval 0.05 to 0.62
|
PRIMARY outcome
Timeframe: 10 daysOutcome measures
| Measure |
Acyline Plus Placebo
n=6 Participants
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
n=7 Participants
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
n=8 Participants
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
|---|---|---|---|---|---|
|
Serum Follicle Stimulating Hormone (FSH)
|
0.41 IU/L
Interval 0.17 to 0.46
|
0.41 IU/L
Interval 0.27 to 0.6
|
0.29 IU/L
Interval 0.24 to 1.0
|
0.28 IU/L
Interval 0.25 to 1.1
|
0.21 IU/L
Interval 0.18 to 0.27
|
PRIMARY outcome
Timeframe: 10 daysOutcome measures
| Measure |
Acyline Plus Placebo
n=6 Participants
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
n=7 Participants
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
n=5 Participants
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
n=8 Participants
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
|---|---|---|---|---|---|
|
Intratesticular Testosterone (ITT-T)
|
77 IU/L
Interval 40.0 to 223.0
|
136 IU/L
Interval 79.0 to 258.0
|
319 IU/L
Interval 139.0 to 2455.0
|
987 IU/L
Interval 895.0 to 1250.0
|
73 IU/L
Interval 34.0 to 264.0
|
Adverse Events
Acyline Plus Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Acyline Plus 15 IU hCG
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Acyline Plus 60 IU hCG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Acyline Plus 125 IU hCG
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Acyline Plus Testosterone Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acyline Plus Placebo
n=6 participants at risk
Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
|
Acyline Plus 15 IU hCG
n=7 participants at risk
ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
|
Acyline Plus 60 IU hCG
n=5 participants at risk
ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus 125 IU hCG
n=5 participants at risk
ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
|
Acyline Plus Testosterone Gel
n=8 participants at risk
ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
|
|---|---|---|---|---|---|
|
Endocrine disorders
hot flashes
|
16.7%
1/6 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
14.3%
1/7 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/8 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Skin and subcutaneous tissue disorders
dry itchy skin
|
0.00%
0/6 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/7 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
12.5%
1/8 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
General disorders
fatigue
|
0.00%
0/6 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/7 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
20.0%
1/5 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/8 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Endocrine disorders
decreased libido
|
0.00%
0/6 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/7 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
20.0%
1/5 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/8 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Reproductive system and breast disorders
testicular soreness
|
0.00%
0/6 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/7 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
20.0%
1/5 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/8 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Nervous system disorders
syncope
|
0.00%
0/6 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/7 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
20.0%
1/5 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/8 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Nervous system disorders
slight dizziness
|
0.00%
0/6 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/7 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/5 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
20.0%
1/5 • Number of events 1 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
0.00%
0/8 • overall study (1 year, 5 months)
The first subject was screened 3/17/09; the last subject exited 8/17/10. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place