KCT0001108
Recruiting
未知
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 Men
Eli Lilly Korea0 sites50 target enrollmentTBD
ConditionsDiseases of The genitoruinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of The genitoruinary system
- Sponsor
- Eli Lilly Korea
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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