A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Me
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0001108
- Lead Sponsor
- Eli Lilly Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Major inclusion criteria include:
* Males at least 18 years of age.
* Total testosterone level <300ng/dl (10.4 nmol/L) at 2 screening visits, Visit 1 and Visit 2, at least 1 week
apart (morning lab collection required between 0700 and 1100 hours).
* At least 1 symptom of testosterone deficiency being studied in this clinical trial (decreased energy or
decreased sexual drive) based on patient report and opinion of the investigator.
* PSA <4 ng/ml at Visit 2.
Major exclusion criteria include:
* Hemoglobin A1c >11% at Visit 2.
* BMI > 37kg/m2 at Visit 2
* Hematocrit =50% at Visit 2. For sites located at geographic elevations =4500 feet (approximately 1370
meters), patients will be excluded with hematocrit >54% at Visit 2, according to investigator discretion. If
any patient at any site regardless of geographic elevation with a hematocrit >54% at later study visits, the
investigational product will be discontinued immediately.
* Dermatologic condition in underarm area that might interfere with testosterone absorption (for example,
eczema) or be exacerbated by topical testosterone replacement therapy.
* Currently receiving treatment with cancer chemotherapy or antiandrogens; current use of systemic
glucocorticoids, 5-alpha reductase inhibitors, or warfarin; or use of non-testosterone anabolic steroids within
the past 12 months prior to visit 1.
* Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of
nonmelanotic skin cancer).
* Clinical suspicion (or history) of prostate cancer during digital rectal examination
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method total testosterone concentration within the normal range (300 - 1050 ng/dL)
- Secondary Outcome Measures
Name Time Method Sexual Arousal, Interest, and Drive (SAID) Scale