ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01215292
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 46
• Location: 1
• Arms: 5
• Duration (Months): 14
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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. to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone.

2. to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a greater degree than acyline alone.

3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2) to a greater degree than acyline alone.

Condition or Disease	Intervention/Treatment	Phase
Healthy Males	Drug: Acyline; Drug: Testosterone gel; Drug: ketoconazole 400; Drug: Ketoconazole 800; Drug: Dutasteride; Drug: Anastrozole; Drug: Placebo ketoconazole	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Mechanisms of Control of the Intratesticular Hormonal Milieu in Man
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Acyline & T Gel & Placebo Ketoconazole 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	Drug: Acyline; 300 mcg/kg on Day 1; Other Names: Acyline GnRH antagonist ; Drug: Testosterone gel; 5 gm of 1% T Gel applied transdermally for 10 days; Other Names: Androgel ; Drug: Placebo ketoconazole; placebo to mimic ketoconazole
Experimental: Acyline & T Gel & Ketoconazole 400 Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10	Drug: Acyline; 300 mcg/kg on Day 1; Other Names: Acyline GnRH antagonist ; Drug: Testosterone gel; 5 gm of 1% T Gel applied transdermally for 10 days; Other Names: Androgel ; Drug: ketoconazole 400; 400 mg PO daily, Days 3-10; Other Names: Teva
Experimental: Acyline & T gel & Ketoconazole 800 Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10	Drug: Acyline; 300 mcg/kg on Day 1; Other Names: Acyline GnRH antagonist ; Drug: Testosterone gel; 5 gm of 1% T Gel applied transdermally for 10 days; Other Names: Androgel ; Drug: Ketoconazole 800; 800 mg PO daily, Day 3-10; Other Names: Teva
Experimental: Acyline & T gel & Dutasteride 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	Drug: Acyline; 300 mcg/kg on Day 1; Other Names: Acyline GnRH antagonist ; Drug: Testosterone gel; 5 gm of 1% T Gel applied transdermally for 10 days; Other Names: Androgel ; Drug: Dutasteride; 2.5 mg PO daily, Day 3-10; Other Names: Avodart
Experimental: Group 5: anastrazole 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	Drug: Acyline; 300 mcg/kg on Day 1; Other Names: Acyline GnRH antagonist ; Drug: Testosterone gel; 5 gm of 1% T Gel applied transdermally for 10 days; Other Names: Androgel ; Drug: Anastrozole; 1 mg PO daily, Day 3-10; Other Names: Arimidex

Outcome Measures

Primary Outcome Measures

1. Intratesticular Testosterone (IT-T) Level [10 days]

2. Intratesticular Dihydrotestosterone (DHT) Level [10 days]

3. Intratesticular Androstenedione (ADD) Level [10 days]

Eligibility Criteria

Criteria

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

INCLUSION CRITERIA:

• 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

EXCLUSION CRITERIA:

• 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

• 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

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
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Mara Y Roth, MD, 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, 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Soriano-Guillén 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. Epub 2004 Nov 2.
• Trachtenberg J, Zadra J. Steroid synthesis inhibition by ketoconazole: sites of action. Clin Invest Med. 1988 Feb;11(1):1-5.
• 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. Review.
• 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.
• 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.

• Responsible Party: Mara Roth, Assistant Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01215292
• Other Study ID Numbers: 38692-K; U54HD012629
• First Posted: Oct 6, 2010
• Last Update Posted: Mar 31, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Mara Roth, Assistant Professor, University of Washington: testosterone; acyline; ketoconazole; dutasteride; anastrazole; Intratesticular hormone concentration
• Additional relevant MeSH terms: Ketoconazole; Anastrozole; Testosterone; Dutasteride; Acyline

Study Results

Participant Flow

Recruitment Details	Healthy men, aged 18-50 years were recruited for this study using newspaper and online advertisement, including flyers posted at the University of Washington, Seattle.
Pre-assignment Detail	Fifty-two men were screened for the study and 46 met all inclusion criteria. Six subjects withdrew from the study prior to any procedures and 40 were randomized (n=8/group. Exclusion criteria included liver disease or adrenal insufficiency, Body Mass Index > 32, abnormal test results, skin conditions for gel, alcohol/drug abuse etc.

Arm/Group Title	Acyline & T Gel & Ketoconazole 400	Acyline & T Gel & Dutasteride	Acyline & T Gel & Placebo Ketoconazole	Acyline & T Gel & Ketoconazole 800	Group 5: Anastrazole
Arm/Group Description	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10	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	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	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10	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
Period Title: Overall Study
STARTED	8	8	8	8	8
COMPLETED	8	8	8	8	8
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Acyline & T Gel & Ketoconazole 400	Acyline & T Gel & Dutasteride	Acyline & T Gel & Placebo Ketoconazole	Acyline & T Gel & Ketoconazole 800	Group 5: Anastrazole	Total
Arm/Group Description	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10	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	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	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10	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	Total of all reporting groups
Overall Participants	8	8	8	8	8	40
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	22.5	21.5	24	22	21.5	22
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	8 100%	8 100%	8 100%	8 100%	8 100%	40 100%
Region of Enrollment (participants) [Number]
United States	8 100%	8 100%	8 100%	8 100%	8 100%	40 100%
Serum FSH (IU/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [IU/L]	2.3	2.7	2.7	2.4	2.3	2.6
Serum Testosterone (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	5.5	5.4	5.2	5.3	5.2	5.3
Serum DHT (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	0.44	0.5	0.5	0.44	0.42	0.46
Serum E2 (pg/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pg/mL]	39	24	28.3	39	39.4	28.3
Serum ADD (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	0.7	0.75	0.76	0.69	0.65	0.67
Serum DHEA (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	3.9	3.9	4.2	4.6	3.8	3.9
Serum 17-OHP (ng/mL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ng/mL]	6	6.1	7.2	4.8	6	6.1
Serum LH (IU/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [IU/L]	5	4.7	4.3	5.8	4.9	4.8

Outcome Measures

1. Primary Outcome

Title	Intratesticular Testosterone (IT-T) Level
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acyline + Testosterone Gel + Placebo	Acyline + Tgel + Ketoconazole 400mg	Acyline + Tgel + Ketoconazole 800mg	Acyline & TGel & Dutasteride 2.5mg	Acyline & TGel & Anastrazole 1mg
Arm/Group Description	300mcg Acyline, 1% testosterone gel 5g daily + placebo	300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole	300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
Measure Participants	8	8	8	8	8
Median (Inter-Quartile Range) [ng/mL]	14	3.7	1.7	18.4	24.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acyline + Testosterone Gel + Placebo, Acyline + Tgel + Ketoconazole 400mg, Acyline + Tgel + Ketoconazole 800mg, Acyline & TGel & Dutasteride 2.5mg, Acyline & TGel & Anastrazole 1mg
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	80% power to detect 20% difference in ITT
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Kruskal-Wallis
	Comments

2. Primary Outcome

Title	Intratesticular Dihydrotestosterone (DHT) Level
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acyline + Testosterone Gel (Tgel)+ Placebo	Acyline & TGel & Ketoconazole 400 mg	Acyline & TGel & Ketoconazole 800 mg	Acyline & TGel & Dutasteride	Acyline & TGel & Anastrazole
Arm/Group Description	Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + placebo	Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + ketoconazole 400mg x 7 days	Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + 800mg ketoconazole x 7 days	Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + dutasteride 2.5mg x 7 days	Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + Anastrazole 1mg x 7 days
Measure Participants	8	8	8	8	8
Median (Inter-Quartile Range) [ng/mL]	3.17	2.08	1.46	0.12	3.63

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acyline + Testosterone Gel + Placebo, Acyline + Tgel + Ketoconazole 400mg, Acyline + Tgel + Ketoconazole 800mg, Acyline & TGel & Dutasteride 2.5mg, Acyline & TGel & Anastrazole 1mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Kruskal-Wallis
	Comments

3. Primary Outcome

Title	Intratesticular Androstenedione (ADD) Level
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acyline + Testosterone Gel (Tgel)+ Placebo	Acyline + Tgel + Ketoconazole 400mg	Acyline + Tgel + Ketoconazole 800mg	Acyline & TGel & Dutasteride 2.5mg	Acyline & TGel & Anastrazole 1mg
Arm/Group Description	Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole	Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
Measure Participants	8	8	8	8	8
Median (Inter-Quartile Range) [ng/mL]	.87	0.5	0.12	1.7	3.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acyline + Testosterone Gel + Placebo, Acyline + Tgel + Ketoconazole 400mg, Acyline + Tgel + Ketoconazole 800mg, Acyline & TGel & Dutasteride 2.5mg, Acyline & TGel & Anastrazole 1mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Arm/Group Title	Acyline & T Gel & Ketoconazole 400		Acyline & T Gel & Dutasteride		Acyline & T Gel & Placebo Ketoconazole		Acyline & T Gel & Ketoconazole 800		Group 5: Anastrazole
Arm/Group Description	Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10		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		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		Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10		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
All Cause Mortality
	Acyline & T Gel & Ketoconazole 400		Acyline & T Gel & Dutasteride		Acyline & T Gel & Placebo Ketoconazole		Acyline & T Gel & Ketoconazole 800		Group 5: Anastrazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Acyline & T Gel & Ketoconazole 400		Acyline & T Gel & Dutasteride		Acyline & T Gel & Placebo Ketoconazole		Acyline & T Gel & Ketoconazole 800		Group 5: Anastrazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)		0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
Endocrine disorders
Testicular hematoma and hematocele	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Other (Not Including Serious) Adverse Events
	Acyline & T Gel & Ketoconazole 400		Acyline & T Gel & Dutasteride		Acyline & T Gel & Placebo Ketoconazole		Acyline & T Gel & Ketoconazole 800		Group 5: Anastrazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/8 (37.5%)		2/8 (25%)		5/8 (62.5%)		6/8 (75%)		5/8 (62.5%)
Endocrine disorders
Decreased libido	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Pain at spermatic cord/at scrotum	0/8 (0%)	0	1/8 (12.5%)	1	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Prostatitis	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
General disorders
Headache	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	3/8 (37.5%)	3	2/8 (25%)	2
Immune system disorders
platar fascitis	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Musculoskeletal and connective tissue disorders
Finger laceration	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Psychiatric disorders
Change in mood/irritability	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Respiratory, thoracic and mediastinal disorders
Seasonal allergies	1/8 (12.5%)	1	0/8 (0%)	0	2/8 (25%)	2	1/8 (12.5%)	1	0/8 (0%)	0
Upper respiratory infection	1/8 (12.5%)	1	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	1/8 (12.5%)	1
Skin and subcutaneous tissue disorders
pruritus/rash	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0
Surgical and medical procedures
abdomenal ecchymosis	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0

Limitations/Caveats

[Not Specified]

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.