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enroll. 19 failed inclusion criteria, 1 withdrew consent before study procedures, 1 dropped out after Day 1, and 1 was withdrawn by the investigator for syncopal reaction. 6 did not suppress serum luteinizing hormone(affecting intratesticular testosterone)and were excluded from analysis.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

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

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
Age, Customized	21 years n=99 Participants	25 years n=107 Participants	22 years n=206 Participants	22 years n=7 Participants	22 years n=31 Participants	22 years n=30 Participants
Sex: Female, Male Female	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	0 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	7 Participants n=107 Participants	5 Participants n=206 Participants	5 Participants n=7 Participants	8 Participants n=31 Participants	31 Participants n=30 Participants
Body Mass Index (BMI)	24.8 kg/m^2 n=99 Participants	24.1 kg/m^2 n=107 Participants	24.9 kg/m^2 n=206 Participants	25.8 kg/m^2 n=7 Participants	23.7 kg/m^2 n=31 Participants	24.1 kg/m^2 n=30 Participants
Serum Luteinizing Hormone (LH)	3.5 IU/L n=99 Participants	3.0 IU/L n=107 Participants	3.4 IU/L n=206 Participants	2.9 IU/L n=7 Participants	3.8 IU/L n=31 Participants	3.4 IU/L n=30 Participants
Serum Follicle Simulating Hormone (FSH)	2.7 IU/L n=99 Participants	2.4 IU/L n=107 Participants	2.6 IU/L n=206 Participants	2.2 IU/L n=7 Participants	1.9 IU/L n=31 Participants	2.4 IU/L n=30 Participants
Serum Testosterone (T)	13.0 nmol/L n=99 Participants	15.0 nmol/L n=107 Participants	14.2 nmol/L n=206 Participants	16.8 nmol/L n=7 Participants	15.0 nmol/L n=31 Participants	14.6 nmol/L n=30 Participants
Serum Dihydrotestosterone (DHT)	1.0 nmol/L n=99 Participants	1.3 nmol/L n=107 Participants	1.2 nmol/L n=206 Participants	0.9 nmol/L n=7 Participants	1.1 nmol/L n=31 Participants	1.1 nmol/L n=30 Participants
Serum Estradiol	89 pmol/L n=99 Participants	65 pmol/L n=107 Participants	62 pmol/L n=206 Participants	77 pmol/L n=7 Participants	86 pmol/L n=31 Participants	77 pmol/L n=30 Participants
Serum 17-Hydroxyprogesterone	4.7 nmol/L n=99 Participants	4.9 nmol/L n=107 Participants	5.9 nmol/L n=206 Participants	4.3 nmol/L n=7 Participants	4.6 nmol/L n=31 Participants	4.9 nmol/L n=30 Participants
Intratesticular Testosterone (ITT-T)	3467 nmol/L n=99 Participants	2425 nmol/L n=107 Participants	1821 nmol/L n=206 Participants	3502 nmol/L n=7 Participants	2933 nmol/L n=31 Participants	2508 nmol/L n=30 Participants
Intratesticular Dihydrotestosterone (ITT-DHT)	18.0 nmol/L n=99 Participants	5.0 nmol/L n=107 Participants	7.6 nmol/L n=206 Participants	18.8 nmol/L n=7 Participants	12.9 nmol/L n=31 Participants	11.9 nmol/L n=30 Participants

PRIMARY outcome

Timeframe: 10 days

Population: 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

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 days

Outcome measures

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 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 days

Outcome measures

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 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 days