Transdermal testosterone gel (Cellegy)
McGriff-Lee, N.J.
Current Opinion in Investigational Drugs 3(11): 1629-1632
2002
ISSN/ISBN: 1472-4472 PMID: 12476964 Document Number: 541551
Cellegy is developing a drug delivery system designed to facilitate the transdermal and topical delivery of testosterone for the potential treatment of male hypogonadism (as Tostrex) and decreased sexual energy in post-menopausal women (asTostrelle) [218118], [314726], [351823]. Following phase III dinical trials of Tostrex for male hypogonadism, initiated in March 2000 [361133], an NDA submission for male hypogonadism was filed in June 2002, after a pre-NDA meeting with the FDA late in 2001 [453374]. By March 2002, phase II/III clinical studies in postmenopausal women were underway in the US [444857].