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Retrospective, Non-interventional Study of Depo-Eligard®.

Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00811876
Acronym
OCT
Enrollment
140
Registered
2008-12-19
Start date
2008-09-30
Completion date
2009-12-31
Last updated
2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer

Brief summary

Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment

Detailed description

The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer. Patient data will be collected after a treatment period of six months.

Interventions

OTHERData Collection on Depo-Eligard exposure

Retrospective, Non-interventional

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization * Patients on treatment with Depo-Eligard® for at least six months * Written consent has been obtained

Design outcomes

Primary

MeasureTime frame
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®After at least 6 months treatment with Depo-Eligard

Secondary

MeasureTime frame
Overall patient assessment of treatment benefitAfter at least 6 months treatment with Depo-Eligard
Measurement of PSA and testosterone levels if availableAfter at least 6 months treatment with Depo-Eligard
Overall evaluation of efficacyAfter a least 6 months treatment with Depo-Eligard

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026