Analysis of serum testosterone concentrations from 117 hypogonadal men in the 84-week clinical study of Aveed indicated that serum testosterone concentrations achieved were inversely correlated with the patient's body weight. In 60 patients with pretreatment body weight of ≥ 100 kg, the mean (±SD) serum testosterone average concentration was 426 ± 104 ng/dL. A higher serum testosterone average concentration (568 ± 139 ng/dL) was observed in 57 patients weighing 65 to 100 kg. A similar trend was also observed for maximum serum testosterone concentrations.
North America, powered by strong demand for advanced TRT products in the ., dominates the global testosterone replacement market by accounting for almost % share in it. In fact, the . occupied about % of the North America market in 2015. Europe follows North America vis-à-vis market share. Other important markets are Asia Pacific, the Middle East and Africa (MEA), and Latin America. Asia Pacific is expected to exhibit speedy growth because of significantly higher healthcare investments. China and India hold out a solid potential for the TRT market. South Korea and Japan too will impact sales positively due to a growing population of geriatrics. In Latin America, Brazil is the primary TRT market with maximum share.
However, in December 2004 the United States the 14-member Food and Drug Administration (FDA) advisory committee, plus voting consultants, for Reproductive Health Drugs unanimously rejected Procter and Gamble's fast-track request for Intrinsa citing concerns about off-label use . In Canada, post-menopausal women have been able to obtain government-approved testosterone treatment since 2002. In Australia, post-menopausal women can use Organon testosterone implants which have to be surgically inserted and last from three to six months.