Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Hypogonadotropic Hypogonadism and Primary Hypogonadism, sponsored by Amneal Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.
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 |
What the finished NCT02110368 record still lists
NCT02110368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (74% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hypogonadotropic Hypogonadism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
RECRUITING
-
Kisspeptin Administration Subcutaneously to Patients With IHH
RECRUITING · Phase 2
-
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
RECRUITING · Phase 2
-
The Molecular Basis of Inherited Reproductive Disorders
RECRUITING
-
Effect of Intranasal Insulin on LH Concentrations in Man
COMPLETED · Phase 1
-
Opioid Antagonism in Hypogonadotropic Hypogonadism
COMPLETED · Phase 1
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
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
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