Trials / Completed
CompletedNCT03261999
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Foresee Pharmaceuticals Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.
Detailed description
This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprolide Mesylate | Subcutaneous injection of 25mg Leuprolide Mesylate |
Timeline
- Start date
- 2017-09-26
- Primary completion
- 2018-11-19
- Completion
- 2019-02-01
- First posted
- 2017-08-25
- Last updated
- 2020-05-04
- Results posted
- 2020-05-04
Locations
21 sites across 5 countries: United States, Czechia, Lithuania, Slovakia, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03261999. Inclusion in this directory is not an endorsement.