Testosterone gel receives FDA approval

Article

The FDA has approved a new testosterone gel (Fortesta) for the treatment of hypogonadism.

The FDA has approved a new testosterone gel (Fortesta) for the treatment of hypogonadism.

The gel is clear, colorless, and odorless. It is gently applied with one finger to the front and inner thighs, and not the upper body. It comes in a metered-dose pump that delivers the correct dose per complete depression.

In a 90-day, multicenter, open-label, phase III trial involving men with hypogonadism, 78% of patients using the gel had an average serum total testosterone concentration within the normal range at day 90. The most common side effect was application site reactions.

"Declining blood levels of testosterone can occur in men beginning as early as age 40," said Adrian Dobs, MD, of Johns Hopkins University School of Medicine, Baltimore, who served as principal investigator of the Fortesta gel phase III clinical trial. "The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems. Fortesta gel is an important new treatment option for men who are diagnosed with low testosterone."

Related Videos
blur image background of corridor in hospital or clinic image | Image Credit @ whyframeshot - stock.adobe.com
Male and female surgeon performing surgery | Image Credit: © Georgii - stock.adobe.com
 Licensed   FILE #:  458906503  Preview Crop  Find Similar  Expand Image DIMENSIONS 8000 x 5333px FILE TYPE JPEG CATEGORY The Environment LICENSE TYPE Standard or Extended A lake in the shape of a recycling sign in the middle of untouched nature | Image Credit: © malp - stock.adobe.com
Dr. Mehmet Asim Bilen in an interview with Urology Times
Anne M. Suskind, MD, MS, FACS, FPMRS, answers a question during a Zoom video interview
blurred clinic hallway
Female doctor using laptop | Image Credit: © nenetus - stock.adobe.com
Related Content
© 2024 MJH Life Sciences

All rights reserved.