Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-06-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acyline; T Gel; placebo dutasteride, placebo ketoconazole
All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.
Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months
Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
placebo dutasteride
placebo oral dutasteride PO daily for 4 months
placebo ketoconazole
placebo ketoconazole daily for 4 months
Acyline; T gel; Ketoconazole; placebo
All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.
Group 2: oral ketoconazole 400 mg + placebo oral dutasteride for 4 months
Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
Ketoconazole
ketoconazole 400 mg PO daily for 4 months
placebo dutasteride
placebo oral dutasteride PO daily for 4 months
Acyline; Tgel; Ketoconazole; Dutasteride
All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.
Group 3: Ketoconazole 400mg orally daily + Dutasteride 2.5 mg orally on day 1, followed by 0.5mg daily for 4 months
Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
Dutasteride
Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months
Ketoconazole
ketoconazole 400 mg PO daily for 4 months
Acyline; Tgel; HCG
All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.
Group 4: Human Chorionic gonadotropin (HCG) 60 IU injection every other day for 4 months.
Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
HCG
HCG 60 IU injection Subcutaneously, every other day for 4 months
Interventions
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Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
Dutasteride
Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months
Ketoconazole
ketoconazole 400 mg PO daily for 4 months
HCG
HCG 60 IU injection Subcutaneously, every other day for 4 months
placebo dutasteride
placebo oral dutasteride PO daily for 4 months
placebo ketoconazole
placebo ketoconazole daily for 4 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In general good health based on normal screening evaluation
* Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH)
* Prostate Specific Antigen (PSA) \< 3.0
* Agrees not to donate blood or participate in another research study during the study
* Informed consent
* Must be willing to use a reliable form of contraception during the study
Exclusion Criteria
* History of testosterone or anabolic steroid abuse in the past
* History of or current skin disorder that will interfere with testosterone gel
* Poor general health or significantly abnormal screening blood results
* History of or current testicular or prostate disease
* History of a bleeding disorder or need for anticoagulation
* History of untreated sleep apnea and/or major psychiatric problems
* BMI \> 32
* History of or current liver disease
* Chronic pain syndrome
* Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
* Use of glucocorticoids or underlying adrenal insufficiency
* Active drug or alcohol abuse within the past year
18 Years
55 Years
MALE
Yes
Sponsors
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University of Washington
OTHER
Responsible Party
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William Bremner
Professor of Medicine
Principal Investigators
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Mara Roth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
William J Bremner, MD, PhD
Role: STUDY_DIRECTOR
University of Washington
Locations
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University of Washington Medical Center (Health Sciences)
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
Roth MY, Page ST, Lin K, Anawalt BD, Matsumoto AM, Snyder CN, Marck BT, Bremner WJ, Amory JK. Dose-dependent increase in intratesticular testosterone by very low-dose human chorionic gonadotropin in normal men with experimental gonadotropin deficiency. J Clin Endocrinol Metab. 2010 Aug;95(8):3806-13. doi: 10.1210/jc.2010-0360. Epub 2010 May 19.
Trachtenberg J, Zadra J. Steroid synthesis inhibition by ketoconazole: sites of action. Clin Invest Med. 1988 Feb;11(1):1-5.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00001449
Identifier Type: -
Identifier Source: org_study_id