Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Summary
This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hypogonadism
Intervention
Nasobol® (Itra-nasal Testosterone), Androderm® (Positive Control)
Location
Quality of Life Medical & Research centre
Tuscon
Arizona
United States
85712
Status
Recruiting
Source
Trimel Biopharma Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00975650
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Testosterone
A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.
Hypogonadism
Condition resulting from deficient gonadal functions, such as GAMETOGENESIS and the production of GONADAL STEROID HORMONES. It is characterized by delay in GROWTH, germ cell maturation, and development of secondary sex characteristics. Hypogonadism can be due to a deficiency of GONADOTROPINS (hypogonadotropic hypogonadism) or due to primary gonadal failure (hypergonadotropic hypogonadism).
Testosterone Congeners
Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.
Nasal Lavage Fluid
Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.
Nasal Cavity
The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.
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PubMed Articles
Low testosterone levels are associated with depression and impaired sexual performance. We examined the association between hypogonadism, sexual function and depression among men with HIV infection in...
Late-onset hypogonadism in middle-aged and elderly men.
To the Editor: Wu et al. (July 8 issue)(1) propose a new definition of late-onset hypogonadism in men that is based on a symptom score in combination with a testosterone threshold. In his editorial, B...
Late-onset hypogonadism in middle-aged and elderly men.
To the Editor: Wu et al. (July 8 issue)(1) propose a new definition of late-onset hypogonadism in men that is based on a symptom score in combination with a testosterone threshold. In his editorial, B...
Late-onset hypogonadism in middle-aged and elderly men.
To the Editor: Wu et al. (July 8 issue)(1) propose a new definition of late-onset hypogonadism in men that is based on a symptom score in combination with a testosterone threshold. In his editorial, B...
Androgen Replacement Therapy After Prostate Cancer Treatment.
Historically, testosterone supplementation has been avoided in men with a history of prostate cancer because of concern about prostate cancer progression or recurrence. However, recently published dat...
