• To create a safe and secure research environment
• To minimize costs associated with clinical research
• To streamline data collection and subject flow

There are many advantages to performing your clinical trial at an independent research center

• Rapid turn around from either an independent or central IRB - less than 1 week turn around for regulatory, budget, and CTA documents.
• Low cost
• Low overhead
• Clear administrative structure
• Easy communication
• Key focus on patient recruitment and retention

Director
Kenneth A. Levey, MD MPH is a Clinical Assistant Professor with a Masters in Public Health who has experience in research design, administration, and compliance. Dr. Levey has designed a large clinical database in Oracle that has been in operation since 2005 at NYU Langone Medical Center.

Senior Research Fellow

Steven R. Goldstein, MD has over 30 years of clinical research experience. He has been the principle investigator in numerous large clinical trials. Dr. Goldstein is a leading innovator in the field of gynecology and has published almost 100 peer reviewed journal articles.

Senior Research Coordinator

Rosemary Wein, RN (rosemary.wein@nyumc.org). Rosemary has over 30 years of experience in clinical research in academic institutions. She is a leading expert in research compliance, FDA regulations, and HIPAA. Her understanding of and experience in clinical trials is key to implementing patient recruitment and retention strategies, compliance, follow through, and study completion.

Research Coordinator

Ruby Wu, NP (ruby@nycwhr.com). Ruby is a clinician - researcher dedicated to the coordination and completion of clinical trials under the direction of Rosemary Wein.

CURRENT RESEARCH STUDIES

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Research Study to Evaluate IV Ferumoxytol in Iron Deficiency Anemia (Protocols: AMAG FER-IDA-301/303)

Sponsor: AMAG Pharmaceuticals

Principal Investigator: Kenneth A. Levey MD MPH

Potentially Eligible Subjects:

1. Male or Female over 18 years of age.

2. Hemoglobin <10 mg/dl

3. Transferrin saturation (TSAT) <20%

4. Unable to use or had poor response to oral iron therapy.   

Opened: 8/20/2011

To enroll please contact Ruby Wu, NP (ruby@nycwhr.com) @ 646 290 9560 or email iviron@nycwhr.com

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Myosure Registry Study - this study uses a novel surgical device.

Sponsor: Hologic, Inc.

Principal Investigator: Kenneth A. Levey MD MPH

Potentially Eligible Subjects:

1. Female over 18 years of age.

2. Having planned in-office procedure to remove fibroids or polyps.

Opened:8/11/2011

To enroll please contact Ruby Wu, NP @ 646 290 9560 or email myosure@nycwhr.com

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Research Study to Evaluate Lotrenex in Severe IBS -D (Protocol: 10LOT01)

Sponsor: Prometheus Laboratories, Inc.

Principal Investigator: Kenneth A. Levey MD MPH

Potentially Eligible Subjects:

1. Female over 18 years of age.

2. Chronic and severe diarrhea perdominant irritable bowel syndrome (IBS-D) for over 6 months.

Opened: 5/1/2011

To enroll please contact Ruby Wu, NP @ 646 290 9560 or email lotrenex@nycwhr.com

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Clinical Trial of Mesafem (Paroxetine mesylate) in the Treatment of Vasomotor Symptoms Associated with Menopause (12 Week study)

Sponsor: Noven Therapeutics,LLC

Principal Investigator: Kenneth A. Levey MD MPH

Potentially Eligible Subjects:

1. You have  7-8 moderate to severe hot flashes per day or 50-60 moderate to severe hot flashes per week for at least the past 30 days.

2. You are over 40 years of age.

3. You can complete an electronic diary.

Opened: 5/13/2011

To enroll please contact Ruby Wu, NP @ 646 290 9560 or email mesafem@nycwhr.com

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Clinical Trials on Vaginal Atrophy (ERC 230 and 231)

Sponsor: Endoceutics, Inc.

Principal Investigator: Steven R. Goldstein, MD

Potentially Eligible Subjects:

1. You no longer have menses

2. You are between 40 and 75 years of age.

3. You have pain with intercourse or another bothersome vaginal complaint.

Opened: 1/15/2011

ENROLLMENT FOR BOTH ERC-230 AND ERC-231 IS CLOSED CURRENT SUBJECTS ARE EXPECTED TO COMPLETE THE COURSE OF THE RESEARCH STUDY

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An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System

Sponsor: Watson Laboratories, Inc.

Principal Investigator: Steven R. Goldstein, MD

Opened: NEW ENROLLMENT FOR THIS STUDY HAS CLOSED WE HAVE MET ENROLLMENT MAXIMUM- CURRENT SUBJECTS ARE EXPECTED TO COMPLETE THE COURSE OF THE RESEARCH STUDY

Status: Ongoing as of 1/21/2011

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Chronic Pelvic Pain Registry

• Sponsor: None
• Principal Investigator: Kenneth A. Levey MD MPH
• Research Staff: Click here to login to the Multi - Institutional Chronic Pelvic Pain Registry
• Opened: January 2005
• Status: Ongoing as of 7/1/2011
• To enroll call Kayee Yam, NP 646 290 9560
• If your institution would like to participate click here for more details.

***If you are an industry sponsor and wish to inquire as to the feasibility of performing a clinical trial at NY Center for Women's Health Research then please email Dr. Levey @ leveyk01@nyumc.org

***If you are a patient or an interested professional and want to view research considered important by Dr. Levey and other researchers and clinicians in pelvic pain and minimally invasive gynecologic surgery and the pelvic pain referral network Please Click Here.