Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044226
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-08-22
Brief Title:
A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia BPH
Sponsor:
Milkhaus Laboratory
Organization:
Milkhaus Laboratory
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of ML-04A in Subjects With Symptomatic Benign Prostatic Hyperplasia
Status:
UNKNOWN
Status Verified Date:
2002-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study Patients must not be diabetic must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form Patients will then undergo blood and urine tests a complete physical examination and history and answer several questionnaires to determine their eligibility Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this studyQualified patients receive free study medication free medical care physical examinations EKG laboratory tests for the duration of the study
Detailed Description:
Patients must be willing to discontinue their current medications being taken for BPH for specified time periods before they become eligible These include Proscar Saw Palmetto and any alpha-blocker drugs
Patients with high blood pressure must be on an acceptable medication that controls this condition
Medications for other conditions may disqualify a patient from eligibilityPatients who are diabetic are not eligible for this study
All patients will at some time during the study receive placebo inactive substance The study medication is given twice a day in liquid form under the tongue There is a 33 chance that you would receive placebo for the duration of the study Neither you nor your doctor will know which treatment you are receiving
Patients with high blood pressure must be on an acceptable medication that controls this condition
Medications for other conditions may disqualify a patient from eligibilityPatients who are diabetic are not eligible for this study
All patients will at some time during the study receive placebo inactive substance The study medication is given twice a day in liquid form under the tongue There is a 33 chance that you would receive placebo for the duration of the study Neither you nor your doctor will know which treatment you are receiving
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None