Phase 4
N=78
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01893281 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Percentage of Participants Achieving Normal Serum Testosterone Levels — 94.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Topical Testosterone Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Normal Serum Testosterone Levels |
94.7 | — |
| SECONDARY Change From Baseline in Serum Testosterone Levels |
354.8 | <0.001 sig |
| SECONDARY Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive |
3.95; 11.84; 44.74; 38.16; 1.32; 0.00 | — |
| SECONDARY Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level |
4.00; 16.00; 44.00; 36.00; 0.00; 0.00 | — |
Summary
This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)] when previously treated with a topical testosterone gel.
Eligibility Criteria
Inclusion Criteria
- Able to read, understand, and provide signed informed consent before starting trial activities related to this study (including discontinuing testosterone replacement therapy prior to Screening)
- Male participants with a diagnosis of hypogonadism and documented biochemical failure (total testosterone 19 at Screening
- Hematocrit ≥50% at Screening. For sites located at elevations ≥4500 feet, participants will be excluded with hematocrit >54% according to investigator discretion. Any participant with a hematocrit >54% at later study visits will be withdrawn from the study
- Significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone and/or sunscreens
- Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or that could be exacerbated by topical testosterone replacement therapy
- History of luteinizing hormone-releasing hormone (LHRH) antagonist or agonist treatment in the 6 months prior to Screening
- Exhibit any evidence of congestive heart failure [New York Heart Association (NYHA) Class 2 or above] within 6 months prior to Screening
- Exhibit evidence of severe renal impairment [creatinine clearance <30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula] at Screening
- Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at Screening
- Any condition that would interfere with the participant's ability to provide informed consent, or comply with study instructions, or would place the participant at increased risk, or might confound the interpretation of the study results
- Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Data sourced from ClinicalTrials.gov (NCT01893281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.