Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone, 1.62% Metered Pump · 1 trial · 2 indications
Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.
Area under the concentration vs. time curve, from time of first dosing to infinity
Maximum reported concentration. Estimated for both baseline
| Arm | Type | Description |
|---|---|---|
| AndroGel | ACTIVE_COMPARATOR | AndroGel (testosterone gel) 1.62% Metered-Dose Pump. One actuation 20.25 mg |
| Testosterone Gel | EXPERIMENTAL | Testosterone Topical Gel, 1.62% Metered Pump. One actuation of 20.25 mg. |
| Name | Type | Description |
|---|---|---|
| Testosterone Topical Gel, 1.62% Metered Pump | DRUG | - |
| AndroGel (testosterone gel) 1.62% Metered-Dose Pump | DRUG | - |
Inclusion Criteria: * Healthy adult men with hypogonadism with testosterone levels \<250ng/dL * 18 to 65 years of age (inclusive) * Have normal PSA \< 4.0ng/mL * Weighing a minimum of 50 kg and having a body mass index between 18.0 and 38.0 kg/m2. * Good health as determined by medical history and ...
Testosterone, 1.62% Metered Pump is used for the treatment of Primary Hypogonadism, a condition in which the body does not produce enough testosterone. It is a topical gel delivered via a metered pump and is being developed by Amneal Pharmaceuticals, Inc. for adult male patients with testosterone deficiency.
Testosterone, 1.62% Metered Pump is being developed by Amneal Pharmaceuticals, Inc., a company traded on the NYSE under the ticker symbol AMRX. The drug is currently in Phase 3 clinical development for the treatment of Primary Hypogonadism.
Testosterone, 1.62% Metered Pump is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of Primary Hypogonadism in adult male patients.
Testosterone, 1.62% Metered Pump has one completed clinical trial, NCT02110368, a Phase 3 bioequivalence study. The trial compared the drug to a reference testosterone topical gel in 32 testosterone-deficient adult male subjects under fasting conditions. The study was conducted in the United States.
Testosterone, 1.62% Metered Pump is being studied as a potential generic version of a reference testosterone topical gel. In the clinical trial NCT02110368, the drug was compared to a reference product to assess bioequivalence in testosterone-deficient adult male subjects under fasting conditions.