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testosterone undecanoate · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | Oral testosterone undecanoate (Andriol) |
| Arm 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Oral testosterone undecanoate (Andriol) | DRUG | treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses |
| Placebo | DRUG | treatment for 12 months with placebo in divided doses |
Inclusion Criteria: * Subjects were at least 50 years of age * A body mass index (BMI) between 18 and 34 kg/m\^2 * Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire) * Calculated free testosterone measurement of \<0.26 nmol/L in the ...
Testosterone undecanoate is used for hypogonadism, a condition in which the body does not produce enough testosterone. It is being studied in symptomatic late-onset hypogonadism in men aged 50 years and older. The drug is an androgen replacement therapy under clinical investigation.
Testosterone undecanoate is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research on this drug for the treatment of hypogonadism.
Testosterone undecanoate is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to evaluate its effects in patients with symptomatic late-onset hypogonadism.
Testosterone undecanoate has one completed Phase 2 clinical trial registered as NCT00434824, titled "Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)." This randomized, double-blind, placebo-controlled trial enrolled 322 male participants aged 50 years and older with hypogonadism.
Yes, testosterone undecanoate is the same as Andriol Testocaps. The clinical trial NCT00434824 refers to the drug as Andriol Testocaps, which is a brand name for testosterone undecanoate. This alternative name may be used in research and clinical settings.