Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety.

Background: Long-term data evaluating the efficacy and safety of oral testosterone undecanoate (oral TU; JATENZO) in adult hypogonadal men provides important information for healthcare professionals who prescribe testosterone replacement therapy (TRT).

Aim: To determine the efficacy and safety of long-term oral TU therapy, including its impact on total testosterone (T) levels and psychosexual functioning.

Methods: Hypogonadal men, between 18 and 75 years old, (mean age 56.

A new oral testosterone undecanoate therapy comes of age for the treatment of hypogonadal men.

Background: A novel formulation of oral testosterone undecanoate (TU) was studied in a long- and short-term phase III trial to evaluate safety and efficacy.

Methods: Hypogonadal men (age 18-65 years; two morning serum testosterone (T) <300 ng/dl with signs/symptoms) were recruited into a 365 day (trial I) or 105 day (trial II), randomized, multicenter trial. Patients were randomized 1:1 to oral TU ( = 161) or T-gel ( = 160) in trial I, and 3:1 to oral TU, twice daily (BID) JATENZO® ( = 166) or a topical T product [Axiron® ( = 56)] in trial II.

A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.

Context: A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.

Objective: Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.

Design: Randomized, active-controlled, open-label study.

Dihydrotestosterone: Biochemistry, Physiology, and Clinical Implications of Elevated Blood Levels.

Benefits associated with lowered serum DHT levels after 5α-reductase inhibitor (5AR-I) therapy in men have contributed to a misconception that circulating DHT levels are an important stimulus for androgenic action in target tissues (e.g., prostate).

The impact of rumination on state paranoid ideation in a nonclinical sample.

Cognitive-behavioral models of paranoia have emphasized the potential role of perseverative thinking styles, such as rumination or worry, in the development, maintenance and exacerbation of paranoid beliefs. This study aimed to experimentally test the hypothesis that rumination may play a role in the maintenance or exacerbation of state paranoid ideation. Following a paranoia induction, 37 nonclinical participants were randomly assigned to either a rumination task or a distraction control condition.

Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation.

Many hypogonadal men prefer oral testosterone (T) treatment. Oral T undecanoate (TU) is available in many countries, but not in the United States. We aimed to assess the pharmacokinetics of oral TU in a new self-emulsifying drug delivery system formulation.

Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting.

Background: Despite highly active antiretroviral therapy (HAART), chronic involuntary weight loss still remains a serious problem in the care of HIV patients. Various alterations in energy metabolism and endocrine regulation have been found to cause loss of lean body mass (LBM) and body cell mass (BCM). Previous studies in HIV-positive men undergoing androgen replacement therapy or treatment with recombinant growth hormone (rGH) have shown partial restoration of LBM, but these treatments have largely been ineffective in eugonadal individuals.