A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

Status Completed

Clinical Trial Summary

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT00522431
Study type	Interventional
Source	Endo Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	August 2007
Completion date	March 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03126656` - Effects of Testosterone on Myocardial Repolarization	Phase 4
Terminated	`NCT02419105` - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors	Phase 3
Withdrawn	`NCT02137265` - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism	N/A
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	`NCT00838838` - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis	N/A
Completed	`NCT00119483` - Older Men and Testosterone	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
Completed	`NCT00857454` - A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations	Phase 3