NCT02234115 is a Phase 3 clinical trial of Leuprolide Mesylate in Prostatic Neoplasms, sponsored by Foresee Pharmaceuticals Co., Ltd..

Who is sponsoring NCT02234115?

NCT02234115 is sponsored by Foresee Pharmaceuticals Co., Ltd..

What drugs are being tested in NCT02234115?

Interventions in NCT02234115: Leuprolide Mesylate.

What condition does NCT02234115 study?

NCT02234115 studies Prostatic Neoplasms.

Is NCT02234115 still recruiting?

NCT02234115 is currently completed. Last updated 20 February 2019.

Are results published for NCT02234115?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-20 · How we verify

NCT02234115

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

Completed Phase 3 Results posted Last updated 20 February 2019

What this trial tests

Phase 3 trial testing Leuprolide Mesylate in Prostatic Neoplasms in 137 participants. Completed in 5 January 2017.

Timeline

1 August 2014

Primary endpoint
30 August 2016

5 January 2017

Quick facts

Lead sponsor	Foresee Pharmaceuticals Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	137
Start date	1 August 2014
Primary completion	30 August 2016
Estimated completion	5 January 2017
Sites	29 locations across United States, Austria, Czechia, Germany, Lithuania, Poland, Slovakia, Taiwan

Drugs / interventions tested

Leuprolide Mesylate — full drug profile →

Conditions studied

Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

Foresee Pharmaceuticals Co., Ltd. — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Efficacy of Leuprolide Mesylate (LMIS 50mg)
Time frame: baseline to 28 days, 28 days to 336 days
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).

Sponsor's own description

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Leuprolide Mesylate

Trials testing the same drug.

NCT03261999 — Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer · Phase 3 · completed

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting

Other Foresee Pharmaceuticals Co., Ltd. trials

Trials by the same sponsor.

NCT07191535 — Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) · Phase 2 · not yet recruiting
NCT06795178 — Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer · Phase 3 · withdrawn
NCT06795191 — Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer · Phase 3 · withdrawn
NCT06334211 — Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers · Phase 1 · completed
NCT04750278 — A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19 · Phase 2, PHASE3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02234115 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Foresee Pharmaceuticals Co., Ltd.
Last refreshed: 20 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02234115.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing