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Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

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Prostatic Neoplasms

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Trial Information

Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot)
formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower
testosterone levels to and maintain them at medically castrate levels in subjects with
prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the
45 mg formulation and assess the safety of this formulation.

Inclusion Criteria:

- Histological diagnosis of prostate cancer

- Need for androgen deprivation treatment for 1 year

- Serum testosterone level ≥ 150 ng/dL

- Life expectancy of at least 18 months

- ECOG Performance status grades 0,1 or 2

Exclusion Criteria:

- Hypersensitivity to leuprolide acetate or polylactic acid

- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy

- History of hypogonadism

Type of Study:


Study Design:

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

Outcome Measure:

Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.

Outcome Time Frame:

Day 32 through Week 52

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

July 2004

Related Keywords:

  • Prostatic Neoplasms
  • Leuprolide
  • Prostatic Neoplasms
  • Testosterone
  • Prostate-specific Antigen
  • Pharmacokinetics
  • luprolide acetate
  • Neoplasms
  • Prostatic Neoplasms



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