T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
NCT ID: NCT01686828
Last Updated: 2018-05-08
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
53 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-06-30
Study Completion Date
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metabolic Effects of Androgenicity in Aging Men and Women
NCT00680797
Aging
Insulin Resistance
COMPLETED
NA
Effect of Testosterone Replacement on Insulin Resistance
NCT00487734
Metabolic Syndrome
Hypogonadism
COMPLETED
PHASE4
Insulin Resistance and Testosterone in Women
NCT00123110
Insulin Resistance
Postmenopause
COMPLETED
PHASE2
CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men
NCT00729859
Healthy
COMPLETED
PHASE2
Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
NCT00365794
Aging
Obesity
Insulin Resistance
+1 more
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators will examine the effects of testosterone on insulin sensitivity and body composition in men. This study may lend greater insight into the increased risk of diabetes evident in men with low circulating levels of testosterone. Three drugs will be used in this study: acyline, given by injection; testosterone (T) gel that is applied to the skin; and letrozole, which is an oral drug that blocks the conversion of androgens (male hormones) to estrogens (female hormones). Acyline inhibits the production of luteinizing hormone (LH) and follicle stimulating hormone (FSH). When acyline stops the production of these hormones, it blocks the signal from the brain that stimulates the testicles to make testosterone. Adding testosterone to acyline will restore physiologic levels of testosterone in some study participants. One group of men will receive T gel with letrozole, an aromatase inhibitor; these men will have normal levels of testosterone but low levels of estrogen in the blood. This design will enable determination of the respective metabolic effects of testosterone and estrogen.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Insulin Resistance
Type 2 Diabetes Mellitus
Obesity
Androgen Deficiency
Metabolic Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acyline & placebo gel & placebo pill
Acyline (300mcg/kg) + placebo transdermal gel + placebo pill daily
Group Type
EXPERIMENTAL
Acyline
Intervention Type
DRUG
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Placebo gel (for Testosterone 1.62% gel)
Intervention Type
DRUG
placebo gel manufactured to mimic Testosterone 1.62% gel
Placebo pill (for Letrozole)
Intervention Type
DRUG
Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
Acyline & Testosterone 1.25g & placebo pill
Acyline (300mcg/kg) + Testosterone gel (1.25g) daily + placebo pill daily
Group Type
EXPERIMENTAL
Acyline
Intervention Type
DRUG
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel
Intervention Type
DRUG
Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
Placebo pill (for Letrozole)
Intervention Type
DRUG
Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
Acyline & Testosterone 5g & placebo pill
Acyline (300mcg/kg) + Testosterone gel (5g) daily + placebo pill daily
Group Type
EXPERIMENTAL
Acyline
Intervention Type
DRUG
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel
Intervention Type
DRUG
Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
Placebo pill (for Letrozole)
Intervention Type
DRUG
Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
Acyline & Testosterone & Letrozole
Acyline (300mcg/kg) + Testosterone gel (5g) daily + letrozole (5mg) daily
Group Type
EXPERIMENTAL
Acyline
Intervention Type
DRUG
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Testosterone 1.62% gel
Intervention Type
DRUG
Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
Letrozole
Intervention Type
DRUG
Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acyline
300 mcg/mL administered subcutaneously (at Day 0, Week 2)
Intervention Type
DRUG
Testosterone 1.62% gel
Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
Intervention Type
DRUG
Letrozole
Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
Intervention Type
DRUG
Placebo gel (for Testosterone 1.62% gel)
placebo gel manufactured to mimic Testosterone 1.62% gel
Intervention Type
DRUG
Placebo pill (for Letrozole)
Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Androgel
Femara
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Prostate-specific antigen (PSA) ≤ 3 ng/mL
* Age 25-55 years
* Ability to understand the study, study procedures and provide informed consent
* Serum total T \> 300 ng/dL
* Normal reproductive history and exam
* International Prostate Symptom Score (IPSS) \< 11
* Age 25-55 years
* Ability to understand the study, study procedures and provide informed consent
* Serum total T \> 300 ng/dL
* Normal reproductive history and exam
* International Prostate Symptom Score (IPSS) \< 11
Exclusion Criteria
* A history of prostate cancer including suspicious digital rectal exam (DRE) or history of highgrade prostatic intraepithelial neoplasia (PIN) on prostate biopsy
* Invasive therapy for benign prostatic hyperplasia (BPH) in the past
* History of acute urinary retention in the previous 3 months
* Current or recent past use of androgenic or anti-androgenic drugs, steroids or drugs which interfere with steroid metabolism (within the last 3 months)
* Current use of statins or glucocorticoids
* Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes mellitus) or skin disease
* A history of or current breast cancer
* Known, untreated obstructive sleep apnea
* Hematocrit \> 50 or \< 34
* Hypersensitivity to any of the drugs used in the study
* History of a bleeding disorder or anticoagulation
* Participation in any other drug study within past 90 days
* History of drug or alcohol abuse within the last 12 months
* Weight \> 280 lbs. or BMI ≥ 33
* Desire for fertility in the next 6 months or current pregnant partner
* Sperm concentration \<14 million/ml
* Significant, uncontrolled hypertension (BP \>160/100 mmHg); subjects with well-controlled BP on medical therapy will be eligible to participate
* Invasive therapy for benign prostatic hyperplasia (BPH) in the past
* History of acute urinary retention in the previous 3 months
* Current or recent past use of androgenic or anti-androgenic drugs, steroids or drugs which interfere with steroid metabolism (within the last 3 months)
* Current use of statins or glucocorticoids
* Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes mellitus) or skin disease
* A history of or current breast cancer
* Known, untreated obstructive sleep apnea
* Hematocrit \> 50 or \< 34
* Hypersensitivity to any of the drugs used in the study
* History of a bleeding disorder or anticoagulation
* Participation in any other drug study within past 90 days
* History of drug or alcohol abuse within the last 12 months
* Weight \> 280 lbs. or BMI ≥ 33
* Desire for fertility in the next 6 months or current pregnant partner
* Sperm concentration \<14 million/ml
* Significant, uncontrolled hypertension (BP \>160/100 mmHg); subjects with well-controlled BP on medical therapy will be eligible to participate
Minimum Eligible Age
25 Years
Maximum Eligible Age
55 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Washington
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Katya Rubinow
Assistant Professor, Division of Metabolism, Endocrinology and Nutrition
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William J Bremner, MD, PhD
Role: STUDY_CHAIR
University of Washington
Stephanie T Page, MD, PhD
Role: STUDY_DIRECTOR
University of Washington
Katya Rubinow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Washington
Seattle, Washington, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Flegal KM. Excess deaths associated with obesity: cause and effect. Int J Obes (Lond). 2006 Aug;30(8):1171-2. doi: 10.1038/sj.ijo.0803313. No abstract available.
Reference Type
BACKGROUND
Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM, McKinlay JB. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 2004 Dec;89(12):5920-6. doi: 10.1210/jc.2003-031719.
Reference Type
BACKGROUND
Yeap BB, Chubb SA, Hyde Z, Jamrozik K, Hankey GJ, Flicker L, Norman PE. Lower serum testosterone is independently associated with insulin resistance in non-diabetic older men: the Health In Men Study. Eur J Endocrinol. 2009 Oct;161(4):591-8. doi: 10.1530/EJE-09-0348. Epub 2009 Aug 6.
Reference Type
BACKGROUND
Muller M, Grobbee DE, den Tonkelaar I, Lamberts SW, van der Schouw YT. Endogenous sex hormones and metabolic syndrome in aging men. J Clin Endocrinol Metab. 2005 May;90(5):2618-23. doi: 10.1210/jc.2004-1158. Epub 2005 Feb 1.
Reference Type
BACKGROUND
Li C, Ford ES, Li B, Giles WH, Liu S. Association of testosterone and sex hormone-binding globulin with metabolic syndrome and insulin resistance in men. Diabetes Care. 2010 Jul;33(7):1618-24. doi: 10.2337/dc09-1788. Epub 2010 Apr 5.
Reference Type
BACKGROUND
Smith MR, Lee H, Fallon MA, Nathan DM. Adipocytokines, obesity, and insulin resistance during combined androgen blockade for prostate cancer. Urology. 2008 Feb;71(2):318-22. doi: 10.1016/j.urology.2007.08.035.
Reference Type
BACKGROUND
Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.
Reference Type
BACKGROUND
Mauras N, Hayes V, Welch S, Rini A, Helgeson K, Dokler M, Veldhuis JD, Urban RJ. Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity. J Clin Endocrinol Metab. 1998 Jun;83(6):1886-92. doi: 10.1210/jcem.83.6.4892.
Reference Type
BACKGROUND
Yialamas MA, Dwyer AA, Hanley E, Lee H, Pitteloud N, Hayes FJ. Acute sex steroid withdrawal reduces insulin sensitivity in healthy men with idiopathic hypogonadotropic hypogonadism. J Clin Endocrinol Metab. 2007 Nov;92(11):4254-9. doi: 10.1210/jc.2007-0454. Epub 2007 Aug 28.
Reference Type
BACKGROUND
Klimcakova E, Roussel B, Kovacova Z, Kovacikova M, Siklova-Vitkova M, Combes M, Hejnova J, Decaunes P, Maoret JJ, Vedral T, Viguerie N, Bourlier V, Bouloumie A, Stich V, Langin D. Macrophage gene expression is related to obesity and the metabolic syndrome in human subcutaneous fat as well as in visceral fat. Diabetologia. 2011 Apr;54(4):876-87. doi: 10.1007/s00125-010-2014-3. Epub 2011 Jan 26.
Reference Type
BACKGROUND
Odegaard JI, Chawla A. Mechanisms of macrophage activation in obesity-induced insulin resistance. Nat Clin Pract Endocrinol Metab. 2008 Nov;4(11):619-26. doi: 10.1038/ncpendmet0976. Epub 2008 Oct 7.
Reference Type
BACKGROUND
Rubinow KB, Snyder CN, Amory JK, Hoofnagle AN, Page ST. Acute testosterone deprivation reduces insulin sensitivity in men. Clin Endocrinol (Oxf). 2012 Feb;76(2):281-8. doi: 10.1111/j.1365-2265.2011.04189.x.
Reference Type
BACKGROUND
Ortega Martinez de Victoria E, Xu X, Koska J, Francisco AM, Scalise M, Ferrante AW Jr, Krakoff J. Macrophage content in subcutaneous adipose tissue: associations with adiposity, age, inflammatory markers, and whole-body insulin action in healthy Pima Indians. Diabetes. 2009 Feb;58(2):385-93. doi: 10.2337/db08-0536. Epub 2008 Nov 13.
Reference Type
BACKGROUND
Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.
Reference Type
BACKGROUND
Xu HZ, Li Y, Zhao YF. [Diagnosis and treatment of osteopathic parathyroid adenoma]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2003 Nov;17(6):446-9. Chinese.
Reference Type
BACKGROUND
Lumeng CN, DelProposto JB, Westcott DJ, Saltiel AR. Phenotypic switching of adipose tissue macrophages with obesity is generated by spatiotemporal differences in macrophage subtypes. Diabetes. 2008 Dec;57(12):3239-46. doi: 10.2337/db08-0872. Epub 2008 Oct 1.
Reference Type
BACKGROUND
Rull A, Camps J, Alonso-Villaverde C, Joven J. Insulin resistance, inflammation, and obesity: role of monocyte chemoattractant protein-1 (or CCL2) in the regulation of metabolism. Mediators Inflamm. 2010;2010:326580. doi: 10.1155/2010/326580. Epub 2010 Sep 23.
Reference Type
BACKGROUND
Bastard JP, Maachi M, Lagathu C, Kim MJ, Caron M, Vidal H, Capeau J, Feve B. Recent advances in the relationship between obesity, inflammation, and insulin resistance. Eur Cytokine Netw. 2006 Mar;17(1):4-12.
Reference Type
BACKGROUND
Chazenbalk G, Bertolotto C, Heneidi S, Jumabay M, Trivax B, Aronowitz J, Yoshimura K, Simmons CF, Dumesic DA, Azziz R. Novel pathway of adipogenesis through cross-talk between adipose tissue macrophages, adipose stem cells and adipocytes: evidence of cell plasticity. PLoS One. 2011 Mar 31;6(3):e17834. doi: 10.1371/journal.pone.0017834.
Reference Type
BACKGROUND
Gilliver SC. Sex steroids as inflammatory regulators. J Steroid Biochem Mol Biol. 2010 May 31;120(2-3):105-15. doi: 10.1016/j.jsbmb.2009.12.015. Epub 2010 Jan 4.
Reference Type
BACKGROUND
Cunningham M, Gilkeson G. Estrogen receptors in immunity and autoimmunity. Clin Rev Allergy Immunol. 2011 Feb;40(1):66-73. doi: 10.1007/s12016-010-8203-5.
Reference Type
BACKGROUND
Bouman A, Moes H, Heineman MJ, de Leij LF, Faas MM. The immune response during the luteal phase of the ovarian cycle: increasing sensitivity of human monocytes to endotoxin. Fertil Steril. 2001 Sep;76(3):555-9. doi: 10.1016/s0015-0282(01)01971-9.
Reference Type
BACKGROUND
Lai JJ, Lai KP, Chuang KH, Chang P, Yu IC, Lin WJ, Chang C. Monocyte/macrophage androgen receptor suppresses cutaneous wound healing in mice by enhancing local TNF-alpha expression. J Clin Invest. 2009 Dec;119(12):3739-51. doi: 10.1172/JCI39335. Epub 2009 Nov 9.
Reference Type
BACKGROUND
Hildebrand F, Thobe BM, Hubbard WJ, Choudhry MA, Pape HC, Chaudry IH. Effects of 17beta-estradiol and flutamide on splenic macrophages and splenocytes after trauma-hemorrhage. Cytokine. 2006 Nov;36(3-4):107-14. doi: 10.1016/j.cyto.2006.11.002. Epub 2007 Jan 4.
Reference Type
BACKGROUND
Qiu Y, Yanase T, Hu H, Tanaka T, Nishi Y, Liu M, Sueishi K, Sawamura T, Nawata H. Dihydrotestosterone suppresses foam cell formation and attenuates atherosclerosis development. Endocrinology. 2010 Jul;151(7):3307-16. doi: 10.1210/en.2009-1268. Epub 2010 Apr 28.
Reference Type
BACKGROUND
Rettew JA, Huet-Hudson YM, Marriott I. Testosterone reduces macrophage expression in the mouse of toll-like receptor 4, a trigger for inflammation and innate immunity. Biol Reprod. 2008 Mar;78(3):432-7. doi: 10.1095/biolreprod.107.063545. Epub 2007 Nov 14.
Reference Type
BACKGROUND
Ribas V, Drew BG, Le JA, Soleymani T, Daraei P, Sitz D, Mohammad L, Henstridge DC, Febbraio MA, Hewitt SC, Korach KS, Bensinger SJ, Hevener AL. Myeloid-specific estrogen receptor alpha deficiency impairs metabolic homeostasis and accelerates atherosclerotic lesion development. Proc Natl Acad Sci U S A. 2011 Sep 27;108(39):16457-62. doi: 10.1073/pnas.1104533108. Epub 2011 Sep 7.
Reference Type
BACKGROUND
Kratz M, Purnell JQ, Breen PA, Thomas KK, Utzschneider KM, Carr DB, Kahn SE, Hughes JP, Rutledge EA, Van Yserloo B, Yukawa M, Weigle DS. Reduced adipogenic gene expression in thigh adipose tissue precedes human immunodeficiency virus-associated lipoatrophy. J Clin Endocrinol Metab. 2008 Mar;93(3):959-66. doi: 10.1210/jc.2007-0197. Epub 2007 Dec 18.
Reference Type
BACKGROUND
Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20. doi: 10.1210/jcem.87.7.8675.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Page ST, Herbst KL, Amory JK, Coviello AD, Anawalt BD, Matsumoto AM, Bremner WJ. Testosterone administration suppresses adiponectin levels in men. J Androl. 2005 Jan-Feb;26(1):85-92.
Reference Type
BACKGROUND
Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A, Casaburi R. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med. 1996 Jul 4;335(1):1-7. doi: 10.1056/NEJM199607043350101.
Reference Type
BACKGROUND
Tricker R, Casaburi R, Storer TW, Clevenger B, Berman N, Shirazi A, Bhasin S. The effects of supraphysiological doses of testosterone on angry behavior in healthy eugonadal men--a clinical research center study. J Clin Endocrinol Metab. 1996 Oct;81(10):3754-8. doi: 10.1210/jcem.81.10.8855834.
Reference Type
BACKGROUND
Bhasin S, Woodhouse L, Casaburi R, Singh AB, Mac RP, Lee M, Yarasheski KE, Sinha-Hikim I, Dzekov C, Dzekov J, Magliano L, Storer TW. Older men are as responsive as young men to the anabolic effects of graded doses of testosterone on the skeletal muscle. J Clin Endocrinol Metab. 2005 Feb;90(2):678-88. doi: 10.1210/jc.2004-1184. Epub 2004 Nov 23.
Reference Type
BACKGROUND
Cuzick J, DeCensi A, Arun B, Brown PH, Castiglione M, Dunn B, Forbes JF, Glaus A, Howell A, von Minckwitz G, Vogel V, Zwierzina H. Preventive therapy for breast cancer: a consensus statement. Lancet Oncol. 2011 May;12(5):496-503. doi: 10.1016/S1470-2045(11)70030-4.
Reference Type
BACKGROUND
Leder BZ, LeBlanc KM, Schoenfeld DA, Eastell R, Finkelstein JS. Differential effects of androgens and estrogens on bone turnover in normal men. J Clin Endocrinol Metab. 2003 Jan;88(1):204-10. doi: 10.1210/jc.2002-021036.
Reference Type
BACKGROUND
Belgorosky A, Guercio G, Pepe C, Saraco N, Rivarola MA. Genetic and clinical spectrum of aromatase deficiency in infancy, childhood and adolescence. Horm Res. 2009;72(6):321-30. doi: 10.1159/000249159. Epub 2009 Oct 21.
Reference Type
BACKGROUND
Campbell KL, Makar KW, Kratz M, Foster-Schubert KE, McTiernan A, Ulrich CM. A pilot study of sampling subcutaneous adipose tissue to examine biomarkers of cancer risk. Cancer Prev Res (Phila). 2009 Jan;2(1):37-42. doi: 10.1158/1940-6207.CAPR-08-0073.
Reference Type
BACKGROUND
Muniyappa R, Lee S, Chen H, Quon MJ. Current approaches for assessing insulin sensitivity and resistance in vivo: advantages, limitations, and appropriate usage. Am J Physiol Endocrinol Metab. 2008 Jan;294(1):E15-26. doi: 10.1152/ajpendo.00645.2007. Epub 2007 Oct 23.
Reference Type
BACKGROUND
Olefsky JM, Glass CK. Macrophages, inflammation, and insulin resistance. Annu Rev Physiol. 2010;72:219-46. doi: 10.1146/annurev-physiol-021909-135846.
Reference Type
BACKGROUND
Rubinow KB, Vaisar T, Chao JH, Heinecke JW, Page ST. Sex steroids mediate discrete effects on HDL cholesterol efflux capacity and particle concentration in healthy men. J Clin Lipidol. 2018 Jul-Aug;12(4):1072-1082. doi: 10.1016/j.jacl.2018.04.013. Epub 2018 Apr 30.
Reference Type
DERIVED
Chao J, Rubinow KB, Kratz M, Amory JK, Matsumoto AM, Page ST. Short-Term Estrogen Withdrawal Increases Adiposity in Healthy Men. J Clin Endocrinol Metab. 2016 Oct;101(10):3724-3731. doi: 10.1210/jc.2016-1482. Epub 2016 Aug 2.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00002641
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
NCT00957034
TERMINATED
PHASE2
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
NCT00438321
TERMINATED
PHASE1
Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
NCT02847806
COMPLETED
PHASE3
Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
NCT00613288
COMPLETED
NA
The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
NCT01533129
COMPLETED
PHASE4
Insulin Sensitivity in Men With the Metabolic Syndrome
NCT00433173
SUSPENDED
NA
Testosterone for Men With Insulin Treated Type 2 Diabetes
NCT00349362
COMPLETED
PHASE4
Testosterone Patch's Effects on the Cardiovascular System and Libido
NCT01208038
COMPLETED
PHASE4
Reandron in Diabetic Men Witn Low Testosterone Level
NCT00613782
COMPLETED
PHASE2/PHASE3
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
NCT01364623
COMPLETED
PHASE1
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
NCT00350701
COMPLETED
PHASE4
Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
NCT00470990
COMPLETED
NA
Efficacy, Pharmacokinetics and Safety of Testosterone
NCT01370369
COMPLETED
PHASE2
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
NCT00141492
COMPLETED
PHASE2
Androgen Deprivation Therapy Study
NCT00743327
TERMINATED
Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism
NCT01084369
TERMINATED
PHASE4
Testosterone Gel Applied to Women With Pituitary Gland Problems
NCT00144391
COMPLETED
PHASE4
Impact of Estradiol Addback
NCT01862835
COMPLETED
PHASE1
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
NCT03118479
TERMINATED
PHASE1
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
NCT00351819
COMPLETED
PHASE2
Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]
NCT00490022
COMPLETED
PHASE1/PHASE2
Effects of Testosterone and Fat Utilization
NCT03289559
COMPLETED
NA
Effect of Testosterone Treatment on Drug Metabolism and Transport
NCT05116293
ACTIVE_NOT_RECRUITING
Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages of Type 2 Diabetes
NCT00479609
UNKNOWN
PHASE3
Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer
NCT00167648
COMPLETED
PHASE2