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NCT02110368 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
A Phase 3 study of Hypogonadotropic Hypogonadism and Primary Hypogonadism, sponsored by Amneal Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02110368 is a Phase 3 study of Hypogonadotropic Hypogonadism and Primary Hypogonadism that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 32 participants, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02110368, a Phase 3 study of Hypogonadotropic Hypogonadism and Primary Hypogonadism, has completed, sponsored by Amneal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
Conditions Studied
Interventions
- DRUG Testosterone Topical Gel, 1.62% Metered Pump
- DRUG AndroGel (testosterone gel) 1.62% Metered-Dose Pump
Study Locations (1)
Florida
- Phase One Solutions, Inc. - Miami Gardens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02110368
The ClinicalTrials.gov registry entry for NCT02110368 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (74% lower). The listed sponsor is Amneal Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 2 interventions - of which Testosterone Topical Gel, 1.62% Metered Pump is the first listed.
NCT02110368 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02110368 about?
NCT02110368 is a clinical study titled "Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions". Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
What is the current status of trial NCT02110368?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2014-03. Estimated completion is 2014-05.
What conditions does trial NCT02110368 study?
This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism, Primary Hypogonadism.
What interventions are being tested in trial NCT02110368?
The interventions under investigation include: Testosterone Topical Gel, 1.62% Metered Pump (DRUG), AndroGel (testosterone gel) 1.62% Metered-Dose Pump (DRUG).
Who is sponsoring clinical trial NCT02110368?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02110368 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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