Trials / Completed
CompletedNCT01257425
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) | Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-02-01
- Completion
- 2012-05-01
- First posted
- 2010-12-09
- Last updated
- 2019-02-08
- Results posted
- 2014-05-26
Locations
22 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01257425. Inclusion in this directory is not an endorsement.