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Testosterone Solution in Hypogonadal Men
NCT01816295Phase 3
Key facts
- Status
- Completed
- Start
- May 2013
- Primary completion
- Oct 2014
- Countries
- 9
- Sponsor
- Eli Lilly and Company
- Modality
- Small Molecules
- Conditions
- Hypogonadism
01
Overview
Phase 3, randomised, double-blind trial in Hypogonadism comparing Placebo Solution with Testosterone Solution (2 arms). Primary endpoint: Number of Participants With Total Serum Testosterone Concentration Within Normal Range at 12 weeks. Started May 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Solution
Placebo Solution applied topically once daily.
Testosterone Solution
Testosterone Solution (Axiron) applied topically once daily.
03
Who it enrols
Men with hypogonadism (total testosterone <300 ng/dL) and symptoms of low energy or sexual drive, excluding those with high PSA, severe obesity, or recent cardiovascular events.
04
Endpoints
Primary
Number of Participants With Total Serum Testosterone Concentration Within Normal Range
Secondary
Change From Baseline in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
Change From Baseline in Hypogonadism Energy Diary (HED) Scores
Number of Participants With Prostate Specific Antigen (PSA) >4 ng/mL
05
Results
Primary endpoints met
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