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Sponsored by: |
Debiopharm S.A. |
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Information provided by: | Debiopharm S.A. |
ClinicalTrials.gov Identifier: | NCT00751790 |
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment >90% of the patients would achieve and maintain castrate levels of serum testosterone.
Condition | Intervention | Phase |
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Locally Advanced or Metastatic Prostate Cancer |
Drug: triptorelin embonate (INN) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open, Non-Comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-Month Formulation in Patients With Advanced Prostate Cancer. |
Enrollment: | 120 |
Study Start Date: | July 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: triptorelin embonate (INN)
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
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Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DEB-TRI6M-301 |
Study First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751790 History of Changes |
Health Authority: | South Africa: Medicines Control Council; United States: Food and Drug Administration |
triptorelin, 6-month formulation, advanced prostate cancer |
Antineoplastic Agents, Hormonal Prostatic Diseases Genital Neoplasms, Male Contraceptive Agents Triptorelin |
Contraceptive Agents, Female Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Urogenital Neoplasms Reproductive Control Agents |
Genital Diseases, Male Luteolytic Agents Pharmacologic Actions Neoplasms Neoplasms by Site Triptorelin Therapeutic Uses Prostatic Neoplasms |