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NCT01816295 · ClinicalTrials.gov registry record · Phase 3
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 715
- Enrollment target
NCT01816295: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01816295 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 715 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816295, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 715 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.
Primary Outcome
Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).
Interventions
- DRUG Placebo Solution
- DRUG Testosterone Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01816295 record still lists
NCT01816295 is an interventional study that assigns participants to a tested intervention. The registered 715 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo Solution is the first listed.
NCT01816295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816295 about?
NCT01816295 is a clinical study titled "A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy". The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or ...
What is the current status of trial NCT01816295?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 715 participants. The study started on 2013-05. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01816295?
The interventions under investigation include: Placebo Solution (DRUG), Testosterone Solution (DRUG).
Who is sponsoring clinical trial NCT01816295?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816295's enrollment target sits among peer trials
715 498th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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