Trial Outcomes & Findings for HOP-2A - Intratesticular Hormone Levels (NCT NCT00756561)

NCT ID: NCT00756561

Last Updated: 2016-06-13

Results Overview

Average between right and left testis for each subject and serum hormone concentration in 10 normal men

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: 6-weeks
• Results posted on: 2016-06-13

Participant Flow

Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle, WA, between September - December 2008. All visits were at the University of Washington, Seattle, WA.

15 screened, 3 did not meet inclusion criteria (2 for abnormal semen parameters, 1 for abnormal liver function), 1 decided not to enroll, and 1 did not complete study procedures because of study end. Data analysis was performed on the first 10 of 11 subjects completing procedures.

Participant milestones

Measure	Healthy Normal Males Men, 18-50 years of age, in good health
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HOP-2A - Intratesticular Hormone Levels

Baseline characteristics by cohort

Measure	Healthy Normal Males n=10 Participants Men, 18-50 years of age, in good health
Age, Continuous Between 18 and 50 years	23 years n=5 Participants
Sex/Gender, Customized Male	10 participants n=5 Participants
Body Mass Index (BMI)	25.9 kg/m^2 n=5 Participants
Sperm concentration	75 millions/mL n=5 Participants
Luteinizing Hormone (LH)	3.7 IU/L n=5 Participants
Follicle Stimulating Hormone (FSH)	1.8 IU/L n=5 Participants
Serum Testosterone (T)	3.0 ng/mL n=5 Participants
Serum Dihydrotestosterone (DHT)	0.20 ng/mL n=5 Participants
Serum Estradiol (E2)	0.025 ng/mL n=5 Participants
Testis volume	25 mL n=5 Participants

PRIMARY outcome

Timeframe: 6-weeks

Population: per protocol

Average between right and left testis for each subject and serum hormone concentration in 10 normal men

Outcome measures

Measure	Intratesticular Concentration n=10 Participants Average intratesticular hormone concentration between right and left testis in 10 normal men	Serum Concentration n=10 Participants Serum hormone concentration in 10 normal men
Intratesticular Hormones in Normal Men Testosterone	486 ng/mL Interval 429.0 to 897.0	3.0 ng/mL Interval 2.3 to 3.9
Intratesticular Hormones in Normal Men Dihydrotestosterone	3.7 ng/mL Interval 1.1 to 4.7	0.20 ng/mL Interval 0.12 to 0.24
Intratesticular Hormones in Normal Men Estradiol	2.7 ng/mL Interval 1.3 to 3.4	0.025 ng/mL Interval 0.019 to 0.029

Adverse Events

Healthy Normal Males

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Normal Males n=11 participants at risk Men, 18-50 years of age, in good health
Reproductive system and breast disorders discomfort at lidocaine injection site	9.1% 1/11 • Number of events 1 • 4 months The first subject was screened 9/26/2008; the last subject exited 1/16/2009. Subjects in the study are asked about adverse events and concomitant medications at every visit.
Musculoskeletal and connective tissue disorders bruised ribs	9.1% 1/11 • Number of events 1 • 4 months The first subject was screened 9/26/2008; the last subject exited 1/16/2009. Subjects in the study are asked about adverse events and concomitant medications at every visit.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	18.2% 2/11 • Number of events 2 • 4 months The first subject was screened 9/26/2008; the last subject exited 1/16/2009. Subjects in the study are asked about adverse events and concomitant medications at every visit.

Additional Information

Mara Roth, MD

University of Washington, Dept. of Medicine

Phone: (206) 221-0519

Email: mylang@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place