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 个研究点目标入组 50 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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

发起方

Eli Lilly Korea