Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hypogonadism
Intervention
Testosterone Undecanoate
Location
Indevus Pharmaceuticals, Inc.
Lexington
Massachusetts
United States
02421
Status
Active, not recruiting
Source
Endo Pharmaceuticals Solutions Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00467870
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
Dihydrotestosterone
A potent androgenic metabolite of TESTOSTERONE. Dihydrotestosterone (DHT) is generated by a 5-alpha reduction of testosterone. Unlike testosterone, DHT cannot be aromatized to ESTRADIOL therefore DHT is considered a pure androgenic steroid.
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.
Testosterone Propionate
An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.
Clinical Trials
Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Treatment of male hypogonadism by testosterone substitution has be monitored in terms of safety. This study relates to safety of a new long-acting preparation.
Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)(COMPLETED)
In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and...
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
The purpose of this pharmacokinetic study is to determine whether oral testosterone ester formulations can be used effectively to treat men with low testosterone.
The purpose of this study is to evaluate the response of a treatment with testosterone undecanoate and determine the levels of total and free testosterone in hypogonadal patients with erec...
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndro...
PubMed Articles
We evaluated the effects of long-term testosterone replacement therapy (TRT) on the bone mineral density (BMD) in obese patients with metabolic syndrome (MS) and late-onset hypogonadism (LOH). Sixty m...
This study aimed to investigate the effect of intramuscular injection of testosterone undecanoate on overall quality of life (QoL) in men with testosterone deficiency syndrome (TDS). A randomized cont...
ABSTRACT Introduction. Elderly men may suffer from late-onset hypogonadism (LOH). The long-term effects of long-acting testosterone undecanoate (TU) in a large number of LOH men have not yet been repo...
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...
