Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone undecanoate- NebidoTM · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Testosterone undecanoate (TU) - NebidoTM | DRUG | Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals |
Inclusion Criteria: * Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency Exclusion Criteria: * Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease wit...
Testosterone undecanoate, marketed as Nebido, is used for the treatment of hypogonadism in males. It is a small molecule endocrine therapy developed by Bayer AG. The drug is currently in Phase 3 clinical development and is intended to address testosterone deficiency in adult men.
Testosterone undecanoate is a form of testosterone, the primary male sex hormone. It works by replacing or supplementing endogenous testosterone in men with hypogonadism, thereby restoring normal testosterone levels and alleviating symptoms associated with testosterone deficiency.
Testosterone undecanoate (Nebido) is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is responsible for the clinical development and commercialization of this product.
Testosterone undecanoate (Nebido) is in Phase 3 clinical development for the treatment of hypogonadism. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to establish its safety and efficacy.
Testosterone undecanoate (Nebido) has one completed Phase 3 clinical trial registered under NCT00220298. This trial, titled 'Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism,' enrolled 96 male participants aged 18 years and older in Germany. The study was uncontrolled and not randomized or double-blinded.
Yes, Testosterone undecanoate is the same as Nebido. Nebido is the brand name for the drug testosterone undecanoate, which is developed by Bayer AG. The drug is used for the treatment of hypogonadism in men and is currently in Phase 3 clinical development.