Open-Label Study of ARD-0403 in Testosterone Deficient Men

Status Completed

Clinical Trial Summary

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT00448955
Study type	Interventional
Source	Ardana Bioscience Ltd
Contact
Status	Completed
Phase	Phase 3
Start date	May 2007
Completion date	February 2008

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Withdrawn	`NCT02137265` - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism	N/A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
Completed	`NCT01887418` - Pharmacokinetic Study of Testosterone Enanthate	Phase 1/Phase 2
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Withdrawn	`NCT00398034` - Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.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	`NCT02921386` - The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate	Phase 2
Completed	`NCT02937740` - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™	Phase 4
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
Completed	`NCT00663793` - ORAL T-6: Oral Androgens in Man-6	Phase 1