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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001108

Enrollment

Registered

2014-05-14

Start date

2013-08-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : - A randomized, double-blind, placebo-controlled, parallel-group, 16-week (4-week screening, 12-week treatment) phase conducted in patients with testosterone deficiency will be followed by a 6-

Eligibility

Sex/Gender

All

Inclusion 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

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 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

Design outcomes

Primary

Measure	Time frame
total testosterone concentration within the normal range (300 - 1050 ng/dL)	—

Secondary

Measure	Time frame
Sexual Arousal, Interest, and Drive (SAID) Scale	—

Countries

Korea, Republic of

Contacts

Public ContactYoungWook Kim

Eli Lilly Korea

Outcome results