Phase
Condition
Hypogonadism
Treatment
N/AClinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Total testosterone level <300 nanogram per deciliter (ng/dL) [10.4 nanomole per Liter (nmol/L)] at each of 2 screening visits
At least 1 symptom of testosterone deficiency, which must include decreased energy ordecreased sexual drive
Prostate Specific Antigen (PSA) <4 nanogram per milliliter (ng/ml) at screening
Exclusion
Exclusion Criteria:
Sexual partner who is or becomes pregnant at any time during the study
Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pelletsin the 6-month period prior to screening
Body Mass Index (BMI) >37 kilogram per square meter (kg/m^2) at screening
Severe lower urinary tract symptoms and/or significant prostate enlargement
Prolactin lab test result of >30 ng/mL at screening
Hemoglobin A1c (HbA1c) >11% at screening
Hematocrit ≥50% (>54% at elevated altitude) at screening
Current use of any medications, herbal, and/or nutritional supplements that caninterfere with testosterone
Dermatologic condition in underarm area that might interfere with testosteroneabsorption (for example, eczema) or be exacerbated by topical testosterone replacementtherapy
Currently receiving treatment with cancer chemotherapy or antiandrogens
Chronic use of systemic glucocorticoids (use for >14 days within the 3 months prior toscreening); use of non-testosterone anabolic steroids within 12 months prior toscreening
Competitive athletes involved in a sport in which they may be screened for anabolicsteroids
History of use of estrogenizing agents within 12 months prior to screening
History of luteinizing hormone-releasing hormone antagonist or agonist treatment inthe last 6 months prior to screening
History of clomiphene or other anti-estrogen treatment in the 3 months prior toscreening
Use of finasteride within 3 months prior to screening, or use of dutasteride within 6months prior to screening
Current use of warfarin or phenprocoumon
History of frequent opioid use: >1 time/week during any week within 30 days prior toscreening
Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine)
Have a history of significant central nervous system injuries or disease (includingstroke, spinal cord injury, or multiple sclerosis) within 6 months prior to screening
Systolic blood pressure >170 or <90 millimeter of mercury (mm Hg) or diastolic bloodpressure >100 or <50 mm Hg at screening or a history of malignant hypertension
History of unstable angina as defined by Braunwald Classification of Unstable Anginaor angina occurring during sexual intercourse in the last 6 months
History of any of the following coronary conditions within 90 days of screening:myocardial infarction, coronary artery bypass graft surgery, percutaneous coronaryintervention (angioplasty or stent placement)
Have any supraventricular arrhythmia with an uncontrolled ventricular response [meanheart rate >100 beats per minute (bpm)] at rest, or have any history of spontaneous orinduced sustained ventricular tachycardia (heart rate >100 bpm for ≥30 seconds), oruse of an automatic internal cardioverter-defibrillator
Have a history of sudden cardiac arrest
Exhibit any evidence of congestive heart failure [New York Heart Association (NYHA)Class 2 or above], within 6 months prior to screening
Have had a new, significant cardiac conduction defect within 90 days prior toscreening
Clinical suspicion (or history) of prostate cancer during digital rectal examinationat screening
Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)
Exhibit evidence of severe renal impairment [creatinine clearance <30 milliliter perminute (mL/min) as determined by the Cockcroft-Gault formula] at screening
Exhibit a history of severe liver disease or clinical evidence of hepatic impairmentat screening
Have a history of human immunodeficiency virus (HIV) infection
Severe sleep apnea
Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (otherthan hypogonadism) that contributes to symptoms of low energy or fatigue
Study Design
Connect with a study center
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Buenos Aires,
ArgentinaSite Not Available
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Caba,
ArgentinaSite Not Available
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Porto Alegre, 90610-970
BrazilSite Not Available
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Sao Jose Rio Preto, 15090-000
BrazilSite Not Available
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São Paulo, 04262-000
BrazilSite Not Available
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Calgary, Alberta
CanadaSite Not Available
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Victoria, British Columbia
CanadaSite Not Available
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Barrie, Ontario
CanadaSite Not Available
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Burlington, Ontario
CanadaSite Not Available
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Kingston, Ontario
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Kitchener, Ontario
CanadaSite Not Available
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London, Ontario
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Sherbrooke, Quebec
CanadaSite Not Available
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Berlin,
GermanySite Not Available
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Halle,
GermanySite Not Available
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Hamburg,
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Hettstedt,
GermanySite Not Available
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Holzminden,
GermanySite Not Available
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Marburg,
GermanySite Not Available
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Münster,
GermanySite Not Available
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Ancona,
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Bergamo,
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Bologna,
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Catania,
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Firenze,
ItalySite Not Available
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Mondiale Della Sanità, 1, 24127
ItalySite Not Available
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Rho, 20017
ItalySite Not Available
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Rome,
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Rozzano,
ItalySite Not Available
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Torino,
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Goyang-Si,
Korea, Republic ofSite Not Available
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Jeon Ju-City,
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Kwang Ju,
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Pusan,
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Seoul,
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San Juan,
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Moscow, 127473
Russian FederationSite Not Available
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Saint Petersburg, 193257
Russian FederationSite Not Available
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Aravaca,
SpainSite Not Available
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Barcelona,
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Coslada,
SpainSite Not Available
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La Coruña,
SpainSite Not Available
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Madrid,
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Majadahonda,
SpainSite Not Available
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London, Greater London
United KingdomSite Not Available
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Manchester, Lancashire M13 9WL
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Hathersage Road, Manchester
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Lichfield, Staffordshire WS14 9JL
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Barnsley,
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Homewood, Alabama
United StatesSite Not Available
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Chandler, Arizona
United StatesSite Not Available
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Glendale, Arizona
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Mesa, Arizona
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Phoenix, Arizona
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Tempe, Arizona
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Tucson, Arizona
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Escondido, California
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Irvine, California
United StatesSite Not Available
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Los Angeles, California
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Spring Valley, California
United StatesSite Not Available
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Colorado Springs, Colorado
United StatesSite Not Available
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Coral Springs, Florida
United StatesSite Not Available
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Daytona Beach, Florida
United StatesSite Not Available
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Fort Lauderdale, Florida
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Jacksonville, Florida
United StatesSite Not Available
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Oviedo, Florida
United StatesSite Not Available
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Plantation, Florida
United StatesSite Not Available
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St. Petersburg, Florida
United StatesSite Not Available
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Idaho Falls, Idaho
United StatesSite Not Available
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Meridian, Idaho
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Crystal Lake, Illinois
United StatesSite Not Available
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Fort Wayne, Indiana
United StatesSite Not Available
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Indianapolis, Indiana
United StatesSite Not Available
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Des Moines, Iowa
United StatesSite Not Available
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Topeka, Kansas
United StatesSite Not Available
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Shreveport, Louisiana
United StatesSite Not Available
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Greenbelt, Maryland
United StatesSite Not Available
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Boston, Massachusetts 02118
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Springfield, Missouri
United StatesSite Not Available
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Las Vegas, Nevada
United StatesSite Not Available
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Englewood, New Jersey
United StatesSite Not Available
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Toms River, New Jersey
United StatesSite Not Available
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Raleigh, North Carolina
United StatesSite Not Available
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Wilmington, North Carolina
United StatesSite Not Available
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Columbus, Ohio
United StatesSite Not Available
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Bala Cynwyd, Pennsylvania
United StatesSite Not Available
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Greer, South Carolina
United StatesSite Not Available
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Mt. Pleasant, South Carolina
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kingsport, Tennessee
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin, Texas
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Houston, Texas
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Clinton, Utah
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bellevue, Washington
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seattle, Washington
United StatesSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Spokane, Washington
United StatesSite Not Available
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