This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to determine how a new intranasal (applied inside the nose) gel formulation of male hormone Testosterone called Nasobol? is metabolized by human body. This will be done by giving different doses of Nasobol? to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remains in blood at set time points. This study will have two groups: hypogonadal men receiving study medication and healthy men not receiving study medication. Blood levels of testosterone in the hypogonadal men will be compared to those in the healthy men. Testosterone levels in healthy men follow a diurnal pattern in which testosterone is high in the morning and gradually declines reaching lowest levels in the early evening. Current marketed formulations of testosterone provide constant serum levels that do not mimic this variation. Nasobol? is an innovative pharmaceutical formulation of testosterone for nasal administration that has the potential advantages of ease of use, the possibility to mimic diurnal variation of serum testosterone levels, no risk of transfer to other people like in the testosterone applied on the skin. Currently, there is no available intranasal testosterone gel available for hypogonadal men in the United States.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000425-41
Application #
8174500
Study Section
Special Emphasis Panel (ZRR1-CR-5 (01))
Project Start
2009-12-01
Project End
2010-11-30
Budget Start
2009-12-01
Budget End
2010-11-30
Support Year
41
Fiscal Year
2010
Total Cost
$18,431
Indirect Cost
Name
La Biomed Research Institute/ Harbor UCLA Medical Center
Department
Type
DUNS #
069926962
City
Torrance
State
CA
Country
United States
Zip Code
90502
Mehta, Puja K; Hermel, Melody; Nelson, Michael D et al. (2018) Mental stress peripheral vascular reactivity is elevated in women with coronary vascular dysfunction: Results from the NHLBI-sponsored Cardiac Autonomic Nervous System (CANS) study. Int J Cardiol 251:8-13
Kim, Se-Min; Cui, Jinrui; Rhyu, Jane et al. (2018) Association between site-specific bone mineral density and glucose homeostasis and anthropometric traits in healthy men and women. Clin Endocrinol (Oxf) 88:848-855
Sharma, Shilpa; Mehta, Puja K; Arsanjani, Reza et al. (2018) False-positive stress testing: Does endothelial vascular dysfunction contribute to ST-segment depression in women? A pilot study. Clin Cardiol 41:1044-1048
Shufelt, Chrisandra; Manson, Joann (2018) Managing Menopause by Combining Evidence With Clinical Judgment. Clin Obstet Gynecol 61:470-479
Cherukuri, Lavanya; Smith, Michael S; Tayek, John A (2018) The durability of oral diabetic medications: Time to A1c baseline and a review of common oral medications used by the primary care provider. Endocrinol Diabetes Metab J 2:
Nicholls, Stephen J; Tuzcu, E Murat; Wolski, Kathy et al. (2018) Extent of coronary atherosclerosis and arterial remodelling in women: the NHLBI-sponsored Women's Ischemia Syndrome Evaluation. Cardiovasc Diagn Ther 8:405-413
Wei, Janet; Bakir, May; Darounian, Navid et al. (2018) Myocardial Scar Is Prevalent and Associated With Subclinical Myocardial Dysfunction in Women With Suspected Ischemia But No Obstructive Coronary Artery Disease: From the Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction Study. Circulation 137:874-876
Elboudwarej, Omeed; Wei, Janet; Darouian, Navid et al. (2018) Maladaptive left ventricular remodeling in women: An analysis from the Women's Ischemia Syndrome Evaluation-Coronary Vascular Dysfunction study. Int J Cardiol 268:230-235
Shufelt, Chrisandra; Bairey Merz, C Noel; Pettinger, Mary B et al. (2018) Estrogen-alone therapy and invasive breast cancer incidence by dose, formulation, and route of delivery: findings from the WHI observational study. Menopause 25:985-991
Nakanishi, Rine; Baskaran, Lohendran; Gransar, Heidi et al. (2017) Relationship of Hypertension to Coronary Atherosclerosis and Cardiac Events in Patients With Coronary Computed Tomographic Angiography. Hypertension 70:293-299

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