Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia

ClinicalTrials.gov ID: NCT00077012

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Official title

A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Transurethral Photodynamic Therapy With QLT0074 for Benign Prostatic Hyperplasia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074. Secondary objectives are: 1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR). 2. To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection. 3. To select up to two transurethral PDT drug-light regimens for further clinical development.

Study identification

NCT ID: NCT00077012
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: QLT Inc.; Industry
Enrollment: Not listed

Conditions and interventions

Conditions

Benign Prostatic Hyperplasia

Interventions

QLT0074 Drug
Photodynamic therapy Drug

Drug

Eligibility (public fields only)

Age range: Not listed
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2003 (Type not available)
Primary completion: May 2005 (Actual)
Completion: May 2005 (Actual)
Last update posted: May 23, 2012

2003 – 2005

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Raymond Fay, MD, Inc	San Francisco	California	94108	—
George Washington University Medical Center	Washington D.C.	District of Columbia	20037	—
Advanced Research Institute Inc	New Port Richey	Florida	34652	—
Carolina Urologic Research Center	Myrtle Beach	South Carolina	29572	—
North Texas Veteran Affairs Health Care System	Dallas	Texas	75216	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00077012, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 23, 2012 · Synced Nov 14, 2026