Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Nymox

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Placebo; Drug: NX-1207

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918983

NX02-0017

Details and patient eligibility

About

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Enrollment: 500 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provide signed informed consent prior to enrolment in the study
2. IPSS ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax < 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

Exclusion criteria

1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume > 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90 days
8. Prostate cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

NX-1207

Experimental group

Treatment:

Drug: NX-1207

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo