ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Silvr, AbbVie will soon have a lot to announce with respect to the Traverse Testosterone study.

Traverse study objectives and design
TRAVERSE (clinicaltrials.gov NCT03518034) is a phase 4, randomized, double-blind, placebo-controlled, non-inferiority, parallel group, multicenter study of transdermal TRT in symptomatic men with hypogonadism who have pre-existing CV disease or increased risk for CV disease. The primary aim of the TRAVERSE study is to determine the safety of TRT with regard to MACE in middle-aged and older men with hypogonadism. The study will enroll approximately 6,000 participants and continue until 256 primary major adverse CV events have been positively adjudicated, with an anticipated study duration of up to 5 years. Because of its long duration and large sample size, the study also provides an opportunity to evaluate prostate safety and several efficacy outcomes, including clinical fractures; sexual activity, sexual desire, and erectile function; remission of late life PDD (dysthymia); progression from prediabetes to diabetes and remission of diabetes; and correction of anemia and incidence of anemia.

Effects of long-term testosterone treatment on cardiovascular outcomes in men with hypogonadism: Rationale and design of the TRAVERSE study

Libigel data should come out soon, as well. They do not list secondary outcomes, it will be interesting to see what additional data was collected.