Hypogonadism Clinical Trial
Official title:
A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
This is an open-study with a 26 week open label treatment period followed by an optional 26 week open label extension. The total treatment period will be 52 weeks.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Low testosterone Exclusion Criteria: - Normal testosterone levels - Elevated Prostatic Specific Antigen (PSA) - History of breast or prostate cancer |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site Reference ID/Investigator# 123943 | Albuquerque | New Mexico |
| United States | Site Reference ID/Investigator# 123948 | Anaheim | California |
| United States | Site Reference ID/Investigator# 123923 | Austin | Texas |
| United States | Site Reference ID/Investigator# 123917 | Bala Cynwyd | Pennsylvania |
| United States | Site Reference ID/Investigator# 123925 | Baltimore | Maryland |
| United States | Site Reference ID/Investigator# 124163 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 124165 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 123895 | Chattanooga | Tennessee |
| United States | Site Reference ID/Investigator# 123947 | Clearwater | Florida |
| United States | Site Reference ID/Investigator# 124162 | Cleveland | Ohio |
| United States | Site Reference ID/Investigator# 124038 | Colorado Springs | Colorado |
| United States | Site Reference ID/Investigator# 125784 | Crestview Hills | Kentucky |
| United States | Site Reference ID/Investigator# 123922 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 124167 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 126202 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 123930 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 123926 | Garden City | New York |
| United States | Site Reference ID/Investigator# 123924 | Greer | South Carolina |
| United States | Site Reference ID/Investigator# 123938 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 123929 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 123931 | Jenkintown | Pennsylvania |
| United States | Site Reference ID/Investigator# 123939 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 124160 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 123932 | Lawrenceville | New Jersey |
| United States | Site Reference ID/Investigator# 123919 | Lexington | Kentucky |
| United States | Site Reference ID/Investigator# 124164 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 123920 | Los Gatos | California |
| United States | Site Reference ID/Investigator# 125782 | Mesa | Arizona |
| United States | Site Reference ID/Investigator# 123936 | Methuen | Massachusetts |
| United States | Site Reference ID/Investigator# 123927 | Middlebury | Connecticut |
| United States | Site Reference ID/Investigator# 123933 | Morehead City | North Carolina |
| United States | Site Reference ID/Investigator# 123946 | Nashville | Tennessee |
| United States | Site Reference ID/Investigator# 125783 | New York | New York |
| United States | Site Reference ID/Investigator# 123940 | Ocala | Florida |
| United States | Site Reference ID/Investigator# 124166 | Orlando | Florida |
| United States | Site Reference ID/Investigator# 124157 | Phoenix | Arizona |
| United States | Site Reference ID/Investigator# 123945 | Ponte Vedra Beach | Florida |
| United States | Site Reference ID/Investigator# 123928 | Poughkeepsie | New York |
| United States | Site Reference ID/Investigator# 123921 | Salisbury | North Carolina |
| United States | Site Reference ID/Investigator# 123944 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 123937 | Tucson | Arizona |
| United States | Site Reference ID/Investigator# 124395 | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of subjects with serum total testosterone average concentration, Cavg(0-24) | Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours. | At Week 12 | No |
| Secondary | Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax) | Cmax is the maximum concentration. | At Week 2, Week 4, Week 12 and Week 52 | No |
| Secondary | Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg) | Cavg is the average concentration. | At Week 2, Week 4, Week 12 and Week 52 | No |
| 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 |
NCT02233751 -
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
|
Phase 1 | |
| Completed |
NCT02222558 -
Oral Testosterone for the Treatment of Hypogonadism in Males
|
Phase 2 | |
| 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 |
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 | |
| Terminated |
NCT00743327 -
Androgen Deprivation Therapy Study
|
N/A |