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].
Download full-text PDF |
Source |
|---|
Publication Analysis
Top Keywords
Similar Publications
Prevalence and predictive factors of testosterone-induced erythrocytosis: a retrospective single center study.
Front Endocrinol (Lausanne)
January 2025
Department of Internal Medicine, Division of Endocrinology, Diabetes and Clinical Nutrition, Luzerner Kantonsspital, Lucerne, Switzerland.
Aim: This study analyzes the prevalence and predictive factors of testosterone-induced erythrocytosis (TIE) in patients receiving testosterone replacement therapy (TRT).
Methods: Retrospective single-center observational study.
Results: 247 patients were included; median age was 47.
Background: Differential diagnosis of hypogonadotropic hypogonadism (HH) and constitutional delay of puberty (CDP) is extremely important since with the latter puberty begins and completes without any medical intervention and in the case of HH puberty does not occur or is incomplete. Failure to start treatment on time leads to medical and psychosocial maladjustment of the patient.
Aim: Development of a method for differential diagnosis of hypogonadotropic hypogonadism and constitutional delay of puberty in boys 13.
Development of a transdermal gel for reversible male contraception.
Contraception
January 2025
Division of Endocrinology, Department of Medicine, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California; Clinical and Translational Science Institute, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
While there are several easy-to-use reversible female contraceptives, little is available for men. Introduction of novel, cost-effective male contraceptives could have important downstream global health and economic benefits. Currently, nearly half of all pregnancies globally are unintended, with many resulting in unsafe abortions, a significant burden for women and families in many countries.
View Article and Find Full Text PDFHigh-dose glucocorticoid treatment vs. glucocorticoid replacement in immune checkpoint inhibitor associated hypophysitis (CORTICI): an open, randomised controlled trial.
Ann Med
December 2025
Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Objective: One of the most severe endocrine side effects of immune checkpoint inhibitors (ICI) is hypophysitis leading to adrenal insufficiency. Recovery is rare, although it has been reported after high-dose glucocorticoid treatment. This is the first randomised study to evaluate whether hormonal recovery differs in patients treated with high-dose glucocorticoids versus glucocorticoid replacement therapy.
View Article and Find Full Text PDFPRDM16 Enhances Osteoblastogenic RUNX2 via Canonical WNT10b/β-CATENIN Pathway in Testosterone-Treated Hypogonadal Men.
Biomolecules
January 2025
Division of Endocrinology Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA.
We previously reported that mediated the improvement in body composition in testosterone (T)-treated hypogonadal men by shifting adipogenesis to myogenesis. Previous preclinical studies suggest that regulates , an important osteoblastic transcription factor, expression and activity. However, the changes in , and other genes/proteins involved in osteoblastogenesis with T therapy in hypogonadal men are unexplored.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!