Trials / Completed
CompletedNCT02212197
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Camurus AB · Industry
- Sex
- Male
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | leuprolide acetate FluidCrystal® injection depot | |
| DRUG | leuprolide acetate |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2015-11-01
- Completion
- 2016-03-01
- First posted
- 2014-08-08
- Last updated
- 2017-04-25
- Results posted
- 2017-02-06
Locations
7 sites across 2 countries: Finland, Hungary
Source: ClinicalTrials.gov record NCT02212197. Inclusion in this directory is not an endorsement.