HOP-2A - Intratesticular Hormone Levels

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00756561
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Male Infertility; Prostate Disease

Detailed Description

We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).

Study Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Intratesticular Hormone Levels in Healthy Young Men
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Outcome Measures

Primary Outcome Measures

1. Intratesticular Hormones in Normal Men [6-weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• males between 18 and 50 years of age

• sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology

• in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)

• body mass index ≥18 and ≤32 kg/m2

• must agree not to participate in another research study involving drug exposure for the duration of the study

Exclusion Criteria:

• men in poor general health, with abnormal blood results

• sperm counts <20 million/ml on two tests

• chronic, ongoing alcohol or drug abuse

• participation in a long-term male contraceptive study within the past three months

• history of testicular or scrotal surgery

• history of infertility

• abnormal testicular exam

• abnormal DRE

• chronic pain syndrome

• use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids

• known bleeding disorder

• use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: John K Amory, MD, MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Dedicated to basic and clinical research focused primarily on the male reproductive system.

Publications

• Anawalt BD, Amory JK, Herbst KL, Coviello AD, Page ST, Bremner WJ, Matsumoto AM. Intramuscular testosterone enanthate plus very low dosage oral levonorgestrel suppresses spermatogenesis without causing weight gain in normal young men: a randomized clinical trial. J Androl. 2005 May-Jun;26(3):405-13.
• Coviello AD, Bremner WJ, Matsumoto AM, Herbst KL, Amory JK, Anawalt BD, Yan X, Brown TR, Wright WW, Zirkin BR, Jarow JP. Intratesticular testosterone concentrations comparable with serum levels are not sufficient to maintain normal sperm production in men receiving a hormonal contraceptive regimen. J Androl. 2004 Nov-Dec;25(6):931-8.
• Coviello AD, Matsumoto AM, Bremner WJ, Herbst KL, Amory JK, Anawalt BD, Sutton PR, Wright WW, Brown TR, Yan X, Zirkin BR, Jarow JP. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005 May;90(5):2595-602. Epub 2005 Feb 15.
• Kalhorn TF, Page ST, Howald WN, Mostaghel EA, Nelson PS. Analysis of testosterone and dihydrotestosterone from biological fluids as the oxime derivatives using high-performance liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2007;21(19):3200-6.
• Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. Epub 2006 Aug 29.
• Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. Epub 2007 May 9.
• Zhao M, Baker SD, Yan X, Zhao Y, Wright WW, Zirkin BR, Jarow JP. Simultaneous determination of steroid composition of human testicular fluid using liquid chromatography tandem mass spectrometry. Steroids. 2004 Oct-Nov;69(11-12):721-6.

• Responsible Party: John Amory, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT00756561
• Other Study ID Numbers: 34593-B
• First Posted: Sep 22, 2008
• Last Update Posted: Jun 13, 2016
• Last Verified: May 1, 2016

• Keywords provided by John Amory, Professor, University of Washington: Fine Needle Aspiration; Male Health; Male Contraception
• Additional relevant MeSH terms: Infertility; Infertility, Male; Prostatic Diseases

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Healthy Normal Males
Arm/Group Description	Men, 18-50 years of age, in good health
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Healthy Normal Males
Arm/Group Description	Men, 18-50 years of age, in good health
Overall Participants	10
Age (years) [Median (Inter-Quartile Range) ]
Between 18 and 50 years	23
Sex/Gender, Customized (participants) [Number]
Male	10 100%
Body Mass Index (BMI) (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	25.9
Sperm concentration (millions/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millions/mL]	75
Luteinizing Hormone (LH) (IU/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [IU/L]	3.7
Follicle Stimulating Hormone (FSH) (IU/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [IU/L]	1.8
Serum Testosterone (T) (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	3.0
Serum Dihydrotestosterone (DHT) (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	0.20
Serum Estradiol (E2) (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	0.025
Testis volume (mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mL]	25

Outcome Measures

1. Primary Outcome

Title	Intratesticular Hormones in Normal Men
Description	Average between right and left testis for each subject and serum hormone concentration in 10 normal men
Time Frame	6-weeks

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Intratesticular Concentration	Serum Concentration
Arm/Group Description	Average intratesticular hormone concentration between right and left testis in 10 normal men	Serum hormone concentration in 10 normal men
Measure Participants	10	10
Testosterone	486	3.0
Dihydrotestosterone	3.7	0.20
Estradiol	2.7	0.025

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	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.
Arm/Group Title	Healthy Normal Males
Arm/Group Description	Men, 18-50 years of age, in good health
All Cause Mortality
	Healthy Normal Males
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Healthy Normal Males
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Normal Males
	Affected / at Risk (%)	# Events
Total	4/11 (36.4%)
Musculoskeletal and connective tissue disorders
bruised ribs	1/11 (9.1%)	1
Reproductive system and breast disorders
discomfort at lidocaine injection site	1/11 (9.1%)	1
Respiratory, thoracic and mediastinal disorders
upper respiratory infection	2/11 (18.2%)	2

Limitations/Caveats

Early termination of study leading to data analysis of the first ten of eleven men receiving aspirations.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.