MedTrace Logo

Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

NCT03297398 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-09-16

Study results available
· View outcomes & findings →

Summary

This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

Group-1 (15mg, OPK-88004)

15mg, OPK-88004

DRUG

Group-2 (25 mg,OPK-88004)

25 mg,OPK-88004

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Militza Vera De Alba, MD · Dr.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2019-04-18
Completion
2019-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297398 on ClinicalTrials.gov