Pharmacokinetic Study of Testosterone Enanthate

Status Completed

Clinical Trial Summary

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Clinical Trial Description

Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events. ;

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT01887418
Study type	Interventional
Source	Antares Pharma Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 2013
Completion date	January 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03126656` - Effects of Testosterone on Myocardial Repolarization	Phase 4
Withdrawn	`NCT02137265` - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism	N/A
Terminated	`NCT02419105` - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors	Phase 3
Completed	`NCT02222558` - Oral Testosterone for the Treatment of Hypogonadism in Males	Phase 2
Completed	`NCT02233751` - Pharmacokinetic Study of Subcutaneous Testosterone Enanthate	Phase 1
Terminated	`NCT01092858` - NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)	Phase 4
Completed	`NCT00624624` - Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism	N/A
Completed	`NCT00752869` - Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement	Phase 4
Completed	`NCT00613288` - Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism	N/A
Completed	`NCT00119483` - Older Men and Testosterone	N/A
Completed	`NCT00838838` - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis	N/A
Completed	`NCT00004438` - Leuprolide in Treating Adults With Hypogonadotropism	N/A
Withdrawn	`NCT00398034` - Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.	Phase 2
Completed	`NCT02937740` - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™	Phase 4
Completed	`NCT02921386` - The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate	Phase 2
Completed	`NCT01717768` - Oral Testosterone for the Treatment of Hypogonadism	Phase 2
Terminated	`NCT01460654` - Testosterone and Alendronate in Hypogonadal Men	Phase 2
Completed	`NCT00998933` - Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure	Phase 1
Withdrawn	`NCT00710827` - Nebido Versus Placebo in Elderly Men With Typical Symptoms of Late Onset Hypogonadism Over a Period of 54 Weeks	Phase 4
Completed	`NCT00857454` - A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations	Phase 3