Tuclar
Phase III Program: Active Enrollment Underway
Based upon input from the Food and Drug Administration (FDA), we are conducting a single pivotal Phase III study to support the filing of a New Drug Application, or NDA. Our open-label pivotal Phase III study will enroll 300 men with low testosterone (T) and is actively enrolling.
Men who have low T levels (regardless of current treatment) who are interested in participating in this clinical study should visit www.lowtstudy.com.
Men will be randomized equally to an Tuclar treatment group or to an active control group treated with the T-gel product, AndroGel®. The 150 men in the Tuclar treatment group will receive Tuclar twice daily, as an oral dose of 200 mg of T with a meal. The study physicians will be able to adjust the Tuclar dose upwards or downwards on days 30 and 60, depending on measured serum T levels.
The primary endpoint for our Phase III study is based solely on the percentage of men in the Tuclar treatment group who achieve an average serum T concentration, or Cavg, in the normal range on day 90 of dosing, without any comparison to AndroGel. The 150 men treated with AndroGel will be considered only when evaluating the safety profile of Tuclar.