A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

Last updated: November 24, 2015
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT01816295
14396
2012-004866-16
I5E-MC-TSAT
  • Ages > 18
  • Male

Study Summary

The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

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

Total Participants: 715
Study Start date:
May 01, 2013
Estimated Completion Date:
April 30, 2015

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    Boston, Massachusetts 02118
    United States

    Site 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.

    Springfield, Missouri
    United States

    Site 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.

    Las Vegas, Nevada
    United States

    Site 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.

    Englewood, New Jersey
    United States

    Site 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.

    Toms River, New Jersey
    United States

    Site 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.

    Raleigh, North Carolina
    United States

    Site 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.

    Wilmington, North Carolina
    United States

    Site 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.

    Columbus, Ohio
    United States

    Site 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.

    Bala Cynwyd, Pennsylvania
    United States

    Site 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.

    Greer, South Carolina
    United States

    Site 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.

    Mt. Pleasant, South Carolina
    United States

    Site 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 States

    Site 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 States

    Site 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 States

    Site 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 States

    Site 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 States

    Site 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 States

    Site 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 States

    Site Not Available

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