Aveed (testosterone undecanoate) is a testosterone replacement therapy indicated for the treatment of hypogonadism in adult men who are associated with a deficiency or absence of the male hormone testosterone.Testosterone decanoate Uses
The testosterone undecanoate was originally discovered by Bayer Pharma, which sold the licence for the development to Endo Pharmaceuticals in the US.
Endo received approval for Aveed from the US Food and Drug Administration (FDA) for treatment of hypogonadism in adult men in March 2014.Hypogonadism is a condition that involves the body’s sex glands producing fewer or no hormones due to the reduced functional activity of the gonads. The disease, depending on the degree of severity, can result in partial or complete infertility.
Aveed contains testosterone undecanoate, which is an ester of testosterone. The drug can be administered using androgen replacement therapy (ART). The testosterone hormone is primarily responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics.
The FDA approval for Aveed was based on the results obtained from a Phase III clinical study conducted for 84 weeks. The single-arm, open label, multicentre clinical study enrolled 130 hypogonadal adult patients who had an average age of 54 years with morning serum total testosterone concentrations