Healthy MalesPhase 1/2ITT4NCT01215292

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

A Phase 1/2 study testing Acyline, Testosterone gel and ketoconazole 400 in people with Healthy Males, 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.

Official record

Search all trials

Trial summary

The purpose of this research study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception. Specific Aims: 1. 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 Males
What is being tested?: Acyline, Testosterone gel and ketoconazole 400
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Mar 2012
Phase: Phase 1/2
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

Who may be able to join

Males age 18-50
Normal serum testosterone, LH and FSH
prostate-specific antigen (PSA) < 4.0
Agrees not to donate blood or participate in another research study during the study
Informed consent
Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
In general good health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry and hematology)
Must be willing to use a reliable form of contraception during the study

Who cannot join

Poor general health, with clinically significant abnormal blood results
Participation in a long-term male contraceptive study within the past three months
Participation in long-term contraceptive or drug study within the past 3 months
History of or current liver disease
Current use of terfenadine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
History of testicular, prostate, or scrotal surgery/trauma or genital abnormal exam

Show all 13Show fewer

BMI > 32
History of sleep apnea and/or major psychiatric problems
Chronic pain syndrome
History of testosterone or anabolic steroid abuse currently or in the past
Known bleeding disorder or current use of anticoagulation
History of or current skin disorder that will interfere with testosterone gel
Unwilling to adhere to protocol-stated restrictions while in the study

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: Mechanisms of Control of the Intratesticular Hormonal Milieu in Man

Specific Aims:

to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone.
to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.
to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2) to a greater degree than acyline alone.

Read the detailed description

Five drugs will be used in this study: acyline, testosterone gel, ketoconazole, dutasteride, and anastrazole.

Acyline suppresses luteinizing hormone (LH) and follicle stimulating hormone (FSH), which are hormones made by the pituitary gland in the brain, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore, acyline blocks testosterone production. Men may experience some side effects from the low levels of testosterone caused by acyline. Acyline is an experimental drug. Over 125 men have received acyline from our lab. Acyline will be given by injection, and injections are formulated by subject's weight and may be given in multiple injections.

Testosterone gel is given to replace testosterone level back to the normal range. Testosterone gel is approved for use in men with low testosterone levels.

Ketoconazole suppresses testosterone production as well. Ketoconazole works in the adrenal glands to prevent testosterone production. It is approved by the U.S. FDA for treatment of fungal infections but for this study the use is considered investigational.

Dutasteride blocks metabolism of testosterone into dihydrotestosterone (DHT). It is approved by the FDA for treatment of benign enlargement of the prostate gland, but the use is considered investigational in this study. Also, the dose is 5 times higher than the FDA approved dose.

Anastrazole blocks metabolism of testosterone into estradiol. It is approved by the FDA for treatment of breast cancer but its use is considered investigational in this study.

Participation will last approximately 2 months. The study involves a minimum of 7 visits. Clinic visits at Screening, Day 3 and Day 10 will take about 1-1.5 hours each. On Day 3 \& 10 a fine needle aspiration of one testis will be performed. The Day 1 visit will take approximately 45 minutes. The Day 7 visit will take about 15 minutes. The Day 17 and Day 40 visits will take approximately 30 minutes each. Over the course of the study, which includes 7 separate blood draws, approximately 12 ounces (one and a half cups) of blood will be drawn. The acyline will be given by injection. The testosterone or placebo gel is applied to the skin on the chest, upper arms, and upper back. The ketoconazole, dutasteride, anastrazole, or placebo medication will be taken by mouth.

Subjects randomly assigned to Group 3 will have a Cosyntropin Stimulation Test performed at the day 10 visit to evaluate the function of adrenal glands.

This is NOT a trial of a male contraceptive, and the study medications will not prevent pregnancy. Subjects must use an acceptable form of birth control.

Conditions: Healthy Males
Being tested: Acyline, Testosterone gel, ketoconazole 400, Ketoconazole 800, Dutasteride
Keywords: testosterone, acyline, ketoconazole, dutasteride, anastrazole, Intratesticular hormone concentration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcylineDrug
Also called Acyline GnRH antagonist
300 mcg/kg on Day 1
Testosterone gelDrug
Also called Androgel
5 gm of 1% T Gel applied transdermally for 10 days
ketoconazole 400Drug
Also called Teva
400 mg PO daily, Days 3-10
Ketoconazole 800Drug
Also called Teva
800 mg PO daily, Day 3-10
DutasterideDrug
Also called Avodart
2.5 mg PO daily, Day 3-10
AnastrozoleDrug
Also called Arimidex
1 mg PO daily, Day 3-10
Placebo ketoconazoleDrug
placebo to mimic ketoconazole

Study groups in NCT01215292
Study group	Role	What they receive
Acyline & T Gel & Placebo Ketoconazole	Placebo comparator	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10 Receives: Drug: Acyline; Drug: Testosterone gel; Drug: Placebo ketoconazole
Acyline & T Gel & Ketoconazole 400	Experimental	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10 Receives: Drug: Acyline; Drug: Testosterone gel; Drug: ketoconazole 400
Acyline & T gel & Ketoconazole 800	Experimental	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10 Receives: Drug: Acyline; Drug: Testosterone gel; Drug: Ketoconazole 800
Acyline & T gel & Dutasteride	Experimental	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10 Receives: Drug: Acyline; Drug: Testosterone gel; Drug: Dutasteride
Group 5: anastrazole	Experimental	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10 Receives: Drug: Acyline; Drug: Testosterone gel; Drug: Anastrozole

What is being measured

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

Intratesticular Testosterone (IT-T) Level
Measured: 10 days
Intratesticular Dihydrotestosterone (DHT) Level
Measured: 10 days
Intratesticular Androstenedione (ADD) Level
Measured: 10 days

Timeline

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

Jan 2011Mar 2012

First posted6 Oct 2010 (estimated)
Study startJan 2011
Primary completionMar 2012
Study completionMar 2012

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 (14)Papers the sponsor has linked to this study.
Other trials for Healthy MalesStudies 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: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215292
Sponsor's protocol ID: 38692-K
Other IDs: U54HD012629
Acronym: ITT4
Status last verified: Feb 2014
First submitted: 4 Oct 2010
Last updated: 31 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.
PubMed 1977002
Wu FC, Farley TM, Peregoudov A, Waites GM. Effects of testosterone enanthate in normal men: experience from a multicenter contraceptive efficacy study. World Health Organization Task Force on Methods for the Regulation of Male Fertility. Fertil Steril. 1996 Mar;65(3):626-36.
PubMed 8774299
Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
PubMed 10386821
Zirkin BR, Santulli R, Awoniyi CA, Ewing LL. Maintenance of advanced spermatogenic cells in the adult rat testis: quantitative relationship to testosterone concentration within the testis. Endocrinology. 1989 Jun;124(6):3043-9. doi: 10.1210/endo-124-6-3043.
PubMed 2498065
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
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
Trachtenberg J, Zadra J. Steroid synthesis inhibition by ketoconazole: sites of action. Clin Invest Med. 1988 Feb;11(1):1-5.
PubMed 2966691
Nashan D, Knuth UA, Weidinger G, Nieschlag E. The antimycotic drug terbinafine in contrast to ketoconazole lacks acute effects on the pituitary-testicular function of healthy men: a placebo-controlled double-blind trial. Acta Endocrinol (Copenh). 1989 May;120(5):677-81. doi: 10.1530/acta.0.1200677.
PubMed 2499150
Pont A, Graybill JR, Craven PC, Galgiani JN, Dismukes WE, Reitz RE, Stevens DA. High-dose ketoconazole therapy and adrenal and testicular function in humans. Arch Intern Med. 1984 Nov;144(11):2150-3.
PubMed 6093722
Van Tyle JH. Ketoconazole. Mechanism of action, spectrum of activity, pharmacokinetics, drug interactions, adverse reactions and therapeutic use. Pharmacotherapy. 1984 Nov-Dec;4(6):343-73. doi: 10.1002/j.1875-9114.1984.tb03398.x.
PubMed 6151171
Soriano-Guillen L, Lahlou N, Chauvet G, Roger M, Chaussain JL, Carel JC. Adult height after ketoconazole treatment in patients with familial male-limited precocious puberty. J Clin Endocrinol Metab. 2005 Jan;90(1):147-51. doi: 10.1210/jc.2004-1438. Epub 2004 Nov 2.
PubMed 15522928
Harris KA, Weinberg V, Bok RA, Kakefuda M, Small EJ. Low dose ketoconazole with replacement doses of hydrocortisone in patients with progressive androgen independent prostate cancer. J Urol. 2002 Aug;168(2):542-5.
PubMed 12131305
Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.
PubMed 15579744
Roth MY, Nya-Ngatchou JJ, Lin K, Page ST, Anawalt BD, Matsumoto AM, Marck BT, Bremner WJ, Amory JK. Androgen synthesis in the gonadotropin-suppressed human testes can be markedly suppressed by ketoconazole. J Clin Endocrinol Metab. 2013 Mar;98(3):1198-206. doi: 10.1210/jc.2012-3527. Epub 2013 Jan 24.
PubMed 23348398

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

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Healthy Male Participants

All Healthy Males trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Control of the Intratesticular Hormonal Milieu in Man
ClinicalTrials.gov ID: NCT01215292
Acronym / sponsor ID: ITT4 / 38692-K
Conditions: Healthy Males
Keywords: testosterone, acyline, ketoconazole, dutasteride, anastrazole, Intratesticular hormone concentration
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Jan 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 29 Jan 2014

Clinical summary

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

Specific Aims:

to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone.
to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.
to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2) to a greater degree than acyline alone.

Detailed description

Five drugs will be used in this study: acyline, testosterone gel, ketoconazole, dutasteride, and anastrazole.

Testosterone gel is given to replace testosterone level back to the normal range. Testosterone gel is approved for use in men with low testosterone levels.

Anastrazole blocks metabolism of testosterone into estradiol. It is approved by the FDA for treatment of breast cancer but its use is considered investigational in this study.

Subjects randomly assigned to Group 3 will have a Cosyntropin Stimulation Test performed at the day 10 visit to evaluate the function of adrenal glands.

This is NOT a trial of a male contraceptive, and the study medications will not prevent pregnancy. Subjects must use an acceptable form of birth control.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Acyline & T Gel & Placebo Ketoconazole	Placebo comparator	Drug: Acyline, Drug: Testosterone gel, Drug: Placebo ketoconazoleAcyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
Acyline & T Gel & Ketoconazole 400	Experimental	Drug: Acyline, Drug: Testosterone gel, Drug: ketoconazole 400Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
Acyline & T gel & Ketoconazole 800	Experimental	Drug: Acyline, Drug: Testosterone gel, Drug: Ketoconazole 800Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
Acyline & T gel & Dutasteride	Experimental	Drug: Acyline, Drug: Testosterone gel, Drug: DutasterideAcyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
Group 5: anastrazole	Experimental	Drug: Acyline, Drug: Testosterone gel, Drug: AnastrozoleAcyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10

Who may qualify

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

Key inclusion criteria (8 listed)

Males age 18-50
Normal serum testosterone, LH and FSH
prostate-specific antigen (PSA) < 4.0
Agrees not to donate blood or participate in another research study during the study
Informed consent

Key exclusion criteria (13 listed)

Poor general health, with clinically significant abnormal blood results
Participation in a long-term male contraceptive study within the past three months
Participation in long-term contraceptive or drug study within the past 3 months
History of or current liver disease
Current use of terfenadine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil

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

Interventions

Intervention	Type	Arms
AcylineAlso: Acyline GnRH antagonist300 mcg/kg on Day 1	Drug	Acyline & T Gel & Ketoconazole 400, Acyline & T Gel & Placebo Ketoconazole, Acyline & T gel & Dutasteride, Acyline & T gel & Ketoconazole 800, Group 5: anastrazole
Testosterone gelAlso: Androgel5 gm of 1% T Gel applied transdermally for 10 days	Drug	Acyline & T Gel & Ketoconazole 400, Acyline & T Gel & Placebo Ketoconazole, Acyline & T gel & Dutasteride, Acyline & T gel & Ketoconazole 800, Group 5: anastrazole
ketoconazole 400Also: Teva400 mg PO daily, Days 3-10	Drug	Acyline & T Gel & Ketoconazole 400
Ketoconazole 800Also: Teva800 mg PO daily, Day 3-10	Drug	Acyline & T gel & Ketoconazole 800
DutasterideAlso: Avodart2.5 mg PO daily, Day 3-10	Drug	Acyline & T gel & Dutasteride
AnastrozoleAlso: Arimidex1 mg PO daily, Day 3-10	Drug	Group 5: anastrazole
Placebo ketoconazoleplacebo to mimic ketoconazole	Drug	Acyline & T Gel & Placebo Ketoconazole

Primary outcome

Intratesticular Testosterone (IT-T) Level
Time frame: 10 days
Intratesticular Dihydrotestosterone (DHT) Level
Time frame: 10 days
Intratesticular Androstenedione (ADD) Level
Time frame: 10 days

Results and safety

Results posted to the registry on 29 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acyline & T Gel & Ketoconazole 400	8	8
Acyline & T Gel & Dutasteride	8	8
Acyline & T Gel & Placebo Ketoconazole	8	8
Acyline & T Gel & Ketoconazole 800	8	8
Group 5: Anastrazole	8	8

Primary outcome: Intratesticular Testosterone (IT-T) Level

Time frame: 10 days. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Acyline + Testosterone Gel + Placebo n = 8	Acyline + Tgel + Ketoconazole 400mg n = 8	Acyline + Tgel + Ketoconazole 800mg n = 8	Acyline & TGel & Dutasteride 2.5mg n = 8	Acyline & TGel & Anastrazole 1mg n = 8
Value	14 (8 to 21.2)	3.7 (2.6 to 7.2)	1.7 (0.9 to 4)	18.4 (15.3 to 24.8)	24.0 (17.7 to 42)

Acyline + Testosterone Gel + Placebo vs Acyline + Tgel + Ketoconazole 400mg vs Acyline + Tgel + Ketoconazole 800mg vs Acyline & TGel & Dutasteride 2.5mg vs Acyline & TGel & Anastrazole 1mg: p <0.05, Kruskal-Wallis

Primary outcome: Intratesticular Dihydrotestosterone (DHT) Level

Time frame: 10 days. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Acyline + Testosterone Gel (Tgel)+ Placebo n = 8	Acyline & TGel & Ketoconazole 400 mg n = 8	Acyline & TGel & Ketoconazole 800 mg n = 8	Acyline & TGel & Dutasteride n = 8	Acyline & TGel & Anastrazole n = 8
Value	3.17 (2.18 to 3.9)	2.08 (1.55 to 2.35)	1.46 (0.75 to 2.25)	0.12 (0.09 to 0.15)	3.63 (1.47 to 4.16)

Acyline + Testosterone Gel (Tgel)+ Placebo vs Acyline & TGel & Ketoconazole 400 mg vs Acyline & TGel & Ketoconazole 800 mg vs Acyline & TGel & Dutasteride vs Acyline & TGel & Anastrazole: p <0.05, Kruskal-Wallis

Primary outcome: Intratesticular Androstenedione (ADD) Level

Time frame: 10 days. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Acyline + Testosterone Gel (Tgel)+ Placebo n = 8	Acyline + Tgel + Ketoconazole 400mg n = 8	Acyline + Tgel + Ketoconazole 800mg n = 8	Acyline & TGel & Dutasteride 2.5mg n = 8	Acyline & TGel & Anastrazole 1mg n = 8
Value	.87 (.67 to 2.1)	0.5 (0.3 to 0.7)	0.12 (0.1 to 0.5)	1.7 (1.14 to 3.0)	3.6 (1.6 to 11.9)

Acyline + Testosterone Gel (Tgel)+ Placebo vs Acyline + Tgel + Ketoconazole 400mg vs Acyline + Tgel + Ketoconazole 800mg vs Acyline & TGel & Dutasteride 2.5mg vs Acyline & TGel & Anastrazole 1mg: p <0.05, Kruskal-Wallis

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acyline & T Gel & Ketoconazole 400	1 of 8 (12.5%)	3 of 8 (37.5%)	Not reported
Acyline & T Gel & Dutasteride	0 of 8 (0%)	2 of 8 (25%)	Not reported
Acyline & T Gel & Placebo Ketoconazole	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Acyline & T Gel & Ketoconazole 800	0 of 8 (0%)	6 of 8 (75%)	Not reported
Group 5: Anastrazole	0 of 8 (0%)	5 of 8 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1977002Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.
Background: PubMed 8774299Wu FC, Farley TM, Peregoudov A, Waites GM. Effects of testosterone enanthate in normal men: experience from a multicenter contraceptive efficacy study. World Health Organization Task Force on Methods for the Regulation of Male Fertility. Fertil Steril. 1996 Mar;65(3):626-36.
Background: PubMed 10386821Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
Background: PubMed 2498065Zirkin BR, Santulli R, Awoniyi CA, Ewing LL. Maintenance of advanced spermatogenic cells in the adult rat testis: quantitative relationship to testosterone concentration within the testis. Endocrinology. 1989 Jun;124(6):3043-9. doi: 10.1210/endo-124-6-3043.
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 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.
Background: PubMed 2966691Trachtenberg J, Zadra J. Steroid synthesis inhibition by ketoconazole: sites of action. Clin Invest Med. 1988 Feb;11(1):1-5.
Background: PubMed 2499150Nashan D, Knuth UA, Weidinger G, Nieschlag E. The antimycotic drug terbinafine in contrast to ketoconazole lacks acute effects on the pituitary-testicular function of healthy men: a placebo-controlled double-blind trial. Acta Endocrinol (Copenh). 1989 May;120(5):677-81. doi: 10.1530/acta.0.1200677.
Background: PubMed 6093722Pont A, Graybill JR, Craven PC, Galgiani JN, Dismukes WE, Reitz RE, Stevens DA. High-dose ketoconazole therapy and adrenal and testicular function in humans. Arch Intern Med. 1984 Nov;144(11):2150-3.
Background: PubMed 6151171Van Tyle JH. Ketoconazole. Mechanism of action, spectrum of activity, pharmacokinetics, drug interactions, adverse reactions and therapeutic use. Pharmacotherapy. 1984 Nov-Dec;4(6):343-73. doi: 10.1002/j.1875-9114.1984.tb03398.x.
Background: PubMed 15522928Soriano-Guillen L, Lahlou N, Chauvet G, Roger M, Chaussain JL, Carel JC. Adult height after ketoconazole treatment in patients with familial male-limited precocious puberty. J Clin Endocrinol Metab. 2005 Jan;90(1):147-51. doi: 10.1210/jc.2004-1438. Epub 2004 Nov 2.
Background: PubMed 12131305Harris KA, Weinberg V, Bok RA, Kakefuda M, Small EJ. Low dose ketoconazole with replacement doses of hydrocortisone in patients with progressive androgen independent prostate cancer. J Urol. 2002 Aug;168(2):542-5.

Related trials for Healthy Males

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Healthy Male Participants

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.

Mara Y Roth, MD 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?

A Phase 1/2 study testing Acyline, Testosterone gel and ketoconazole 400 in people with Healthy Males, 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 8 inclusion and 13 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 31 Mar 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2014). 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 Testosterone (IT-T) Level (time frame: 10 days). The study lists 3 primary outcomes in all. 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 NCT01215292, which also lists 14 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 31 Mar 2014.