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

• Sponsor: Nymox Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00759135
• Collaborator: (none)
• Enrollment: 85
• Locations: 30
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia (BPH); Enlarged Prostate	Drug: 2.5 mg NX-1207; Drug: 0.125 mg NX-1207; Drug: finasteride	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Single therapeutic dose of 2.5 mg NX-1207	Drug: 2.5 mg NX-1207; Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
Experimental: 2 Single low dose of 0.125 mg NX-1207 for dose-response evaluation	Drug: 0.125 mg NX-1207; Low dose; single intraprostatic injection of 0.125 mg NX-1207
Active Comparator: 3 5.0 mg finasteride q.d.	Drug: finasteride; Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

Outcome Measures

Primary Outcome Measures

1. Change in BPH Symptom Score (AUA SI) [90 days]

Secondary Outcome Measures

1. Change in Prostate Volume [90 days]

2. Change in Qmax [90 days]

3. Change in BPH Symptom Score (AUA SI) [30 days]

4. Change in BPH Symptom Score (AUA SI) [180 days]

5. Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug [180 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nymox Investigational Site	Huntsville	Alabama	United States
2	Nymox Investigational Site	Tucson	Arizona	United States
3	Nymox Investigational Site	Little Rock	Arkansas	United States
4	Nymox Investigational Site	Anaheim	California	United States
5	Nymox Investigational Site	Atherton	California	United States
6	Nymox Investigational Site	Long Beach	California	United States
7	Nymox Investigational Site	Modesto	California	United States
8	Nymox Investigational Site	Newport Beach	California	United States
9	Nymox Investigational Site	Denver	Colorado	United States
10	Nymox Investigational Site	New Britain	Connecticut	United States
11	Nymox Investigational Site	Sarasota	Florida	United States
12	Nymox Investigational Site	Greenwood	Indiana	United States
13	Nymox Investigational Site	Jeffersonville	Indiana	United States
14	Nymox Investigational Site	Shreveport	Louisiana	United States
15	Nymox Investigational Site	Missoula	Montana	United States
16	Nymox Investigational Site	Las Vegas	Nevada	United States
17	Nymox Investigational Site	Lawrenceville	New Jersey	United States
18	Nymox Investigational Site	Marlton	New Jersey	United States
19	Nymox Investigational Site	Voorhees	New Jersey	United States
20	Nymox Investigational Site	Garden City	New York	United States
21	Nymox Investigational Site	Poughkeepsie	New York	United States
22	Nymox Investigational Site	Staten Island	New York	United States
23	Nymox Investigational Site	Lancaster	Pennsylvania	United States
24	Nymox Investigational Site	Myrtle Beach	South Carolina	United States
25	Nymox Investigational Site	Germantown	Tennessee	United States
26	Nymox Investigational Site	Arlington	Texas	United States
27	Nymox Investigational Site	Brownsville	Texas	United States
28	Nymox Investigational Site	Dallas	Texas	United States
29	Nymox Investigational Site	McAllen	Texas	United States
30	Nymox Investigational Site	San Antonio	Texas	United States

Sponsors and Collaborators

• Nymox Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nymox Corporation
• ClinicalTrials.gov Identifier: NCT00759135
• Other Study ID Numbers: NX02-0016
• First Posted: Sep 25, 2008
• Last Update Posted: Jun 14, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Nymox Corporation: Benign Prostatic Hyperplasia; BPH; Enlarged Prostate
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Finasteride

Study Results

No Results Posted as of Jun 14, 2012