Prostatic HyperplasiaPhase 2NCT00044226
A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).
A Phase 2 study testing ML-04A in people with Prostatic Hyperplasia, run by Milkhaus Laboratory at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- ML-04A
- How many people
- 350 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2002to Oct 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
- Have an enlarged prostate by DRE (digital rectal examination);
- Have a diagnosis of BPH;
- Have documented symptoms (frequency; urgency; nighttime urination; reduced flow);
- Have a documented urinary flow rate as required
Trial locations and contacts
14 sites in 1 country.
Martha J. DuRuz-Lynch, BA contact
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Joel Kaufman, MD
Aurora, Colorado, 80012
Jamie Yingst, 303-755-1625
- Recruiting
Edward Loizides, MD
Bay Shore, New York, 11706
Diana Mauceri, RN, 631-665-3737 ext. 132
Kerri Weingard, NP, 631.665.3737
- Recruiting
Donald Bergner, MD
Clearwater, Florida, 33761
Shirley Spiot, 727-724-3316
Becky, 727.724.3316
- Recruiting
Douglas Young, MD
Fair Oaks, California, 95628
Stephanie Lanam, 916-961-7593
- Recruiting
H. Pat Hezmall, MD
Fort Worth, Texas, 73104
Kathy Marshall, 817-332-8595
- Recruiting
Sheldon Freedman, MD
Las Vegas, Nevada, 89109
Lisa Boyak, 702-732-0282
Cynthia Freedman, 702.732.0282
- Recruiting
Charles White, MD
Mobile, Alabama, 36608
Julie Clark, 251-639-1661
- Recruiting
Ira Klimberg, MD
Ocala, Florida, 34474
Rustina Jones, 352-237-3949
- Recruiting
Michael Godschalk, MD
Richmond, Virginia, 23249
Tammy Creasy, RN, 804-675-5705
- Recruiting
Gary Friedlander, MD
Rockville, Maryland, 20850
Wendy Clover, 301-315-6081
- Recruiting
Richard Landau, MD
Sellersville, Pennsylvania, 18960
LouAnn Crist, RN, 215-257-3066
Trista Rochon, 215.540.5870
- Recruiting
Roger Fincher, MD
Spokane, Washington, 99202
Sarah Collins, 509-747-7900
- Recruiting
Rodney Anderson, MD
Stanford, California, 94305
Nushin Namazi, 650-724-0084
- Recruiting
Eugene Dula, MD
Van Nuys, California, 91405
Sandro Gomez, 818-901-8541
Bunny Petretti, 818.901.8541
About this study
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
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 study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.
Read the 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 eligibility.Patients 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.
- Conditions
- Prostatic Hyperplasia
- Being tested
- ML-04A
- Keywords
- BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Enlarged Prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-04ADrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2002 (estimated)
- Study startApr 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Milkhaus Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044226
- Sponsor's protocol ID
- ML-BPH-01
- Status last verified
- Aug 2002
- First submitted
- 22 Aug 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00044226
- Acronym / sponsor ID
- ML-BPH-01
- Conditions
- Prostatic Hyperplasia
- Keywords
- BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Enlarged Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants
- Lead sponsor
- Milkhaus LaboratoryIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Oct 2002
- First posted
- 23 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study.Qualified 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 eligibility.Patients 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ML-04A | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha J. DuRuz-Lynch, BA contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ML-04A in people with Prostatic Hyperplasia, run by Milkhaus Laboratory at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha J. DuRuz-Lynch, BA (414.425.6566), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.