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NCT03792477 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT03792477: Completed Phase 1 study, sponsored by Pfizer.
NCT03792477 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03792477, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.
Primary Outcome
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Interventions
- BIOLOGICAL Test formulation
- BIOLOGICAL Reference formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-01-19 |
| Est. Completion | 2020-04-02 |
| Phase | Phase 1 |
What the finished NCT03792477 record still lists
NCT03792477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Test formulation is the first listed.
NCT03792477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03792477 about?
NCT03792477 is a clinical study titled "A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males". This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the ...
What is the current status of trial NCT03792477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2019-01-19. Estimated completion is 2020-04-02.
What interventions are being tested in trial NCT03792477?
The interventions under investigation include: Test formulation (BIOLOGICAL), Reference formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03792477?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03792477's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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