Phase
Condition
Hypogonadism
Treatment
N/AClinical Study ID
Ages 18-80 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Voluntarily sign and date the study consent form(s) which have been approved by anInstitutional Review Board (IRB). Written consent must be obtained prior to theinitiation of any study procedures.
- Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadismprior to age 65.
- Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples obtained nogreater than 1-4 weeks apart between 6 and 10 AM following an appropriate washout ofcurrent androgen replacement therapy if not testosterone naive. Historical values fromthe past 6 months may be used.
- Testosterone Therapy naive, OR off any testosterone therapy for at least 4 months ORagree to a 4-month washout of current testosterone therapy prior to entry at Visit 1.
- Average office blood pressure measurement <140 millimetre of mercury (mmHg) SBP -AND- <90 mmHg DBP.
- If the participant is on an antihypertensive regimen, he has been on it for at least 4weeks.
- Judged to be in good general health as determined by the principal investigator basedupon the results of a medical history, physical examination, vital signs, laboratoryprofile and a 12-lead electrocardiogram (ECG).
Exclusion
Exclusion Criteria:
- History of significant sensitivity or allergy to androgens, castor oil or productexcipients.
- Clinically significant findings in the pre-study examinations including abnormalbreast examination requiring follow-up, an abnormal ECG.
- Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) orInternational Prostate Symptom Score (I-PSS) score > 19 points.
- Body mass index (BMI) ≥ 35 kg/m^2.
- Clinically significant abnormal laboratory value, in the opinion of the investigator,in serum chemistry, hematology, or urinalysis including but not limited to:
- Prostate specific antigen (PSA) > 4 ng/mL
- Hematocrit < 35% or > 50%
- Baseline hemoglobin > 16 g/dL
- Hemoglobin A1C (HbA1C) > 9.0%
- Estimated glomerular filtration rate (eGFR) <45
- History of seizures or convulsions, including febrile, alcohol or drug withdrawalseizures.
- History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration except for diabetes, or renal disease.
- History of stroke or myocardial infarction within the past 5 years.
- History of, or current or suspected, prostate or breast cancer.
- History of diagnosed, severe, untreated, obstructive sleep apnea.
- History of abuse of alcohol or any drug substance in the opinion of the investigatorwithin the previous 2 years.
- Currently using tobacco, e-cigarettes or other nicotine containing products.
- History of nasal disorders such as nasal surgery; nasal trauma resulting in nasalfracture within the previous 6 months or nasal fracture that caused a deviatedanterior nasal septum; or sinus surgery or sinus disease.
- Receipt of any investigational product within 4 weeks of study start.
- Inability to understand and provide written informed consent for the study.
- Considered by the investigator or the sponsor-designated physician, for any reason, asan unsuitable candidate to receive Natesto.
- Participants working night-shifts.
- Participants performing strenuous manual labor while wearing the ABPM monitor.
- Participants with chronic atrial fibrillation (interferes with the ability to obtainprecise ambulatory recordings).
Study Design
Connect with a study center
Alabama Clinical Therapeutics
Birmingham, Alabama 35235
United StatesActive - Recruiting
Horizon Clinical Research Associates
Phoenix, Arizona 85295
United StatesSite Not Available
Eclipse Clinical Research
Tucson, Arizona 85745
United StatesSite Not Available
Preferred Research Partners
Little Rock, Arkansas 72211
United StatesActive - Recruiting
Valley Clinical Trials
Northridge, California 91325
United StatesActive - Recruiting
Lynn Institute of the Rockies
Colorado Springs, Colorado 80918
United StatesSite Not Available
Excel Medical Clinical Trials
Boca Raton, Florida 33434
United StatesActive - Recruiting
Florida Healthcare Associates
Boynton Beach, Florida 33435
United StatesActive - Recruiting
New Horizon Research Center
Miami, Florida 33165
United StatesActive - Recruiting
University of Miami
Miami, Florida 33146
United StatesActive - Recruiting
NanoHealth Associates
Miami Beach, Florida 33140
United StatesActive - Recruiting
Urology Center of Florida
Pompano Beach, Florida 33060
United StatesActive - Recruiting
Precision Clinical Research
Sunrise, Florida 33351
United StatesActive - Recruiting
Investigative Clinical Research of Indiana
Elwood, Indiana 46036
United StatesActive - Recruiting
Urology of Indiana
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Tandem Clinical Research GI, LLC
Marrero, Louisiana 70072
United StatesActive - Recruiting
Advanced Biomedical Research of America
Las Vegas, Nevada 89123
United StatesActive - Recruiting
Premier Urology Group
Edison, New Jersey 08837
United StatesActive - Recruiting
AccuMed Research Associates
Garden City, New York 11530
United StatesActive - Recruiting
ProHEALTH Care Associates
Garden City, New York 11042
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
The Research Foundation for the State University of New York at Buffalo
Williamsville, New York 14221
United StatesActive - Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Warren Alpert School of Medicine Brown University
Providence, Rhode Island 02903
United StatesSite Not Available
Coastal Carolina Research Center
North Charleston, South Carolina 29405
United StatesActive - Recruiting
North Austin Urology
Austin, Texas 78750
United StatesSite Not Available
Coastal Bend Clinical Research
Corpus Christi, Texas 78413
United StatesSite Not Available
Prime Revival Research Institute
Flower Mound, Texas 76201
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
Crossroads Clinical Research
Victoria, Texas 78413
United StatesActive - Recruiting
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