Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

Nymox

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia (BPH); Enlarged Prostate

Treatments: Drug: 0.125 mg NX-1207; Drug: 2.5 mg NX-1207; Drug: finasteride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759135

NX02-0016

Details and patient eligibility

About

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.

Full description

Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Enrollment: 85 patients

Sex: Male

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Documented history of BPH for at least 1 year
2. AUA SI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax < 15 mL/sec

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. Surgery or MIST in the previous 12 months for treatment of BPH
5. Post-void residual urine volume > 350 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 3 patient groups

1

Experimental group

Description:

Single therapeutic dose of 2.5 mg NX-1207

Treatment:

Drug: 2.5 mg NX-1207

2

Experimental group

Description:

Single low dose of 0.125 mg NX-1207 for dose-response evaluation

Treatment:

Drug: 0.125 mg NX-1207

3

Active Comparator group

Description:

5.0 mg finasteride q.d.

Treatment:

Drug: finasteride