HealthyHOP-2ANCT00756561

HOP-2A - Intratesticular Hormone Levels

An observational study of Healthy and Male Infertility, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy, Male Infertility, Prostate Disease
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Dec 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Study population: Healthy males

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Intratesticular Hormone Levels in Healthy Young Men

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

Read the 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).

Conditions: Healthy, Male Infertility, Prostate Disease
Keywords: Fine Needle Aspiration, Male Health, Male Contraception
Medical subject headings: Infertility, Male, Prostatic Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

Intratesticular Hormones in Normal Men
Average between right and left testis for each subject and serum hormone concentration in 10 normal men
Measured: 6-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Dec 2009

First posted22 Sep 2008 (estimated)
Study startSep 2008
Primary completionJan 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00756561
Sponsor's protocol ID: 34593-B
Acronym: HOP-2A
Status last verified: May 2016
First submitted: 18 Sep 2008
Last updated: 13 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.
PubMed 16940442
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. doi: 10.2164/jandrol.04135.
PubMed 15867009
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. doi: 10.1002/j.1939-4640.2004.tb03164.x.
PubMed 15477366
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. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15.
PubMed 15713727
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. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.
PubMed 17494097
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. doi: 10.1016/j.steroids.2004.05.020.
PubMed 15579324
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. doi: 10.1002/rcm.3205.
PubMed 17764104
Roth MY, Lin K, Amory JK, Matsumoto AM, Anawalt BD, Snyder CN, Kalhorn TF, Bremner WJ, Page ST. Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl. 2010 Mar-Apr;31(2):138-45. doi: 10.2164/jandrol.109.008391. Epub 2009 Sep 24.
PubMed 19779211

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intratesticular Hormone Levels in Healthy Young Men
ClinicalTrials.gov ID: NCT00756561
Acronym / sponsor ID: HOP-2A / 34593-B
Conditions: Healthy, Male Infertility, Prostate Disease
Keywords: Fine Needle Aspiration, Male Health, Male Contraception
Study type: Observational
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Study start: Sep 2008
Primary completion: Jan 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 22 Sep 2008 (estimated)
Results: Posted 19 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy males

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

Results posted to the registry on 19 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Normal Males	10	10

Primary outcome: Intratesticular Hormones in Normal Men

Time frame: 6-weeks. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Intratesticular Concentration n = 10	Serum Concentration n = 10
Testosterone	486 (429 to 897)	3.0 (2.3 to 3.9)
Dihydrotestosterone	3.7 (1.1 to 4.7)	0.20 (0.12 to 0.24)
Estradiol	2.7 (1.3 to 3.4)	0.025 (0.019 to 0.029)

Population analysed: per protocol

Adverse events

Time frame: 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Normal Males	0 of 11 (0%)	4 of 11 (36.4%)	Not reported

Limitations and caveats (from the sponsor): Early termination of study leading to data analysis of the first ten of eleven men receiving aspirations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16940442Page 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. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.
Background: PubMed 15867009Anawalt 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. doi: 10.2164/jandrol.04135.
Background: PubMed 15477366Coviello 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. doi: 10.1002/j.1939-4640.2004.tb03164.x.
Background: PubMed 15713727Coviello 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. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15.
Background: PubMed 17494097Page 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. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.
Background: PubMed 15579324Zhao 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. doi: 10.1016/j.steroids.2004.05.020.
Background: PubMed 17764104Kalhorn 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. doi: 10.1002/rcm.3205.
Results publication: PubMed 19779211Roth MY, Lin K, Amory JK, Matsumoto AM, Anawalt BD, Snyder CN, Kalhorn TF, Bremner WJ, Page ST. Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl. 2010 Mar-Apr;31(2):138-45. doi: 10.2164/jandrol.109.008391. Epub 2009 Sep 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John K Amory, MD, MPH principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Male Infertility, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intratesticular Hormones in Normal Men (time frame: 6-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00756561, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.