Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00857454 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
NCT00857454: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00857454 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857454, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
Study Summary
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.
Primary Outcome
Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema \[beet redness\] to slight eschar formation \[injuries in depth\]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema \[raised more than 1 millimeter and extending beyond area of exposure\]. The total Draize score ranges from 0 to 8.
Interventions
- DRUG Testosterone MD-Lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00857454 record still lists
NCT00857454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Testosterone MD-Lotion is the first listed.
NCT00857454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00857454 about?
NCT00857454 is a clinical study titled "A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations". Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone ...
What is the current status of trial NCT00857454?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2008-10. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00857454?
The interventions under investigation include: Testosterone MD-Lotion (DRUG).
Who is sponsoring clinical trial NCT00857454?
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 NCT00857454's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05452889 · 71 participants · Early Phase 1
PET Image in PAH Patients
- NCT05766943 · 71 participants · NA
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
- NCT06229678 · 71 participants · Early Phase 1
Ketones, SGLT2, HFrEF
- NCT06377566 · 71 participants · Phase 2
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia