Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
NCT00056654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2008-09-17
Summary
The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
Conditions
- Prostatic Neoplasms
Interventions
- DRUG
-
Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2004-07-31
- Completion
- 2004-07-31
Countries
- United States
Study Locations
More Related Trials
-
Study of Lupron Depot In The Treatment of Central Precocious Puberty
NCT00660010 ·Status: COMPLETED ·Phase: PHASE3
-
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
NCT03716739 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer
NCT00167648 ·Status: COMPLETED ·Phase: PHASE2
-
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
NCT02167893 ·Status: COMPLETED
-
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
NCT00161421 ·Status: COMPLETED ·Phase: PHASE2
-
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
NCT07278362 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue
NCT00490555 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
NCT03118479 ·Status: TERMINATED ·Phase: PHASE1
-
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
NCT01386567 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
NCT02081300 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
NCT05205837 ·Status: TERMINATED ·Phase: PHASE4
-
PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
NCT01327495 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Testosterone Replacement in Renal Failure
NCT02712944 ·Status: TERMINATED ·Phase: PHASE1
-
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
NCT04731376 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Leuprolide in Determining the Cause of Gonadotropin Deficiency
NCT00004426 ·Status: COMPLETED ·Phase: NA
-
A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
NCT02651688 ·Status: COMPLETED ·Phase: PHASE2
-
Androgen Deprivation Therapy Study
NCT00743327 ·Status: TERMINATED
-
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
NCT01893281 ·Status: COMPLETED ·Phase: PHASE4
-
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17
NCT06312761 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Pharmacokinetic Study to Determine Time to Steady-state
NCT00911586 ·Status: COMPLETED ·Phase: PHASE2
-
Leuprolide in Treating Adults With Hypogonadotropism
NCT00004438 ·Status: COMPLETED ·Phase: NA
-
Anastrozole Administration in Elderly Hypogonadal Men
NCT00136695 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
NCT01993212 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
NCT01386606 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
NCT01403116 ·Status: COMPLETED ·Phase: PHASE3