Center Overview

PHOENIX Ob Gyn Associates, L.L.C. (PHOENIX), was founded in 1980 and offers comprehensive gynecologic, obstetric and wellness care for women, as well as participating in clinical research studies. Having five board-certified OB/GYN physicians, two certified nurse practitioners, and 2 full time clinical research coordinators, PHOENIX allows for individualized care and impeccable, controlled, efficient research.

Our guiding principles have remained unchanged since our inception. Patient care is our primary focus with a strong commitment to education and advancement of knowledge. PHOENIX keeps abreast of new technologies and medical advancements, offering state-of-the-art care to our patients. PHOENIX believes in the fundamental right of women to comprehensive care, and provides women with a full range of medical services and health options. We promote the health of the community, and provide a variety of educational programs and materials for the public.

Clinical Research Experience

Over the past eight years, PHOENIX Ob Gyn Associates, L.L.C. has participated in Phase II-IV research in areas as varied as hypoactive sexual desire disorder, estrogen replacement therapy, devices, heavy menstrual bleeding, menopausal symptoms, uterine fibroids, osteoporosis prevention, vaginal infections, contraception, endometriosis, post-operative pain management, wound closure, and other obstetric and gynecologic states.

The sponsors and CROs that we have worked with include:

Pharmaceutical Companies

• Tap
• Johnson and Johnson
• Novartis
• Organon
• Ortho McNeil
• Pfizer
• Lilly
• Aventis
• Ross
• Wyeth-Ayerst
• Teva
• Sepracor
• Barrier Therapeutics
• Duramed
• Xanodyne
• 3M Pharmaceuticals
• Upsher-Smith
• Novo Nordisk
• Alza
• Essential Group
• Neurocrine Biosciences
• QuatRx
• FemmPharma
• Third Wave Technologies
• KV Pharmaceutical
• Berlex
• Bayer
• Boehringer Ingelheim
• Proctor & Gamble
• Ethicon
• Focus Diagnostics

CROs

• Pharmanet
• Quintiles
• PPD
• Paragon
• Omnicare
• SFBC
• Premier
• Metropolitan Research Associates
• LBR Regulatory
• Symbio
• Health Decisions
• Essential

Facility Description

PHOENIX Ob Gyn Associates, L.L.C has 3 convenient offices to serve our patients. Our main research site is located in historic Moorestown, New Jersey. Situated approximately 20 miles from Philadelphia, and 20 miles from Trenton, New Jersey, the office is close to I-295, the Atlantic City Expressway, the Pennsylvania Turnpike and Exit 5 of the New Jersey Turnpike. We are also located approximately 30 minutes from Philadelphia International Airport.

Facilities on site include diagnostic hysteroscopy, endometrial sampling, ultrasound (transabdominal and transvaginal), colposcopy, and LEEP cone biopsies. We offer complete inpatient and outpatient gynecologic care including services for adolescent, adult, menopausal and geriatric patients. We do complex hysteroscopic and laparoscopic surgery. Our onsite staff performs ultrasounds, ECGs, cystometric studies and venipunctures. Full radiographic services are located within 5 minutes of PHOENIX.

Clinical research site features include:

• Experienced research staff
• Onsite ultrasound
• Full service laboratory
• Refrigeration and Freezer facilities
• Double Locked storage for research supplies/drugs
• Wireless Internet capability

Investigator Experience

Bruce J. Levine, M.D., F.A.C.O.G., C.P.I. Chief Medical Officer/Principal Investigator/Certified Physician Investigator

Areas of Expertise: Menopause, osteoporosis, fertility, premenstrual syndrome, hormone imbalance, endometriosis, pelvic pain, high-risk pregnancy, contraception, sexually transmitted diseases, laser technology, ultrasonography, and surgical technologies.

Publications:

• Levine, BJ: The Study Budget: An Important Aspect of Clinical Trial Site Success, The Monitor 2007; 21:30
• Levine, BJ, Damaraju CV, Garguilo K, Hewitt DJ: Fentanyl Iontophoretic Transdermal System For Postoperative Pain Management Following Pelvic Surgery, Abstract, Presented at the 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, San Diego May 18, 2007
• Levine BJ, Gabbe SG: Non-Immune Hydrops Fetalis-How to Improve Survival, Contemporary Ob/Gyn 1985; 25:43
• Levine BJ, Eisenberg E, Wallach EE: Luteal Phase Defect: An Association with Endometriosis, Abstract, Presented at the 39th Annual Meeting of the American Fertility Society, San Francisco April 18,1983
• Zeldis SM, Levine BJ, Michelson EL, Morganroth J: Cardiovascular Complaints-Correlation with Cardiac Arrhythmias in 24-Hour Electrocardiographic Monitoring, Chest 1980; 78:456

Clinical research experience as principal investigator:

• 10/07
  Bayer Healthcare Pharmaceuticals – Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses in vitro 12 ug/24 h and 16 ug/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a minimum of 3 years in women 18 to 35 years of age.

• 10/07
  Bayer Healthcare Pharmaceuticals – A multicenter, open-label, single-arm study to assess the efficacy and safety of the oral contraceptive SH T00186D (0.02 mg ethinyl estradiol as betadex clathrate and 3 mg drospirenone) in a flexible extended regimen in 1356 healthy females for 1 year

• 8/07
  Proctor and Gamble- A Randomized, double-blind, placebo-controlled, Multicenter, 52-week study to evaluate the endometrial safety of a transdermal testosterone in naturally postmenopausal women with hypoactive sexual desire disorder

• 7/07
  Boehringer Ingelheim – A twenty-four week, randomized, double-blind, placebo-controlled, safety and efficacy trial of flibanserin 25mg and 50mg once and twice daily in premenopausal women with hypoactive sexual desire disorder in North America

• 2/07
  Berlex- A multicenter, randomized, open label, parallel group, active control study to evaluate the efficacy and safety of of LNG IUS (Mirena) as compared to medroxy progesterone acetate during 6 cycles of treatment in patients with idiopathic Menorrhagia.

• 1/07
  FemmePharma- A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Multicenter Evaluation of the use of Topically Administered Danazol versus Placebo in Subjects with Pain Associated with Fibrocystic Breast Disease

• 1/07
  KV Pharmaceutical- A Phase 2 Clinical Study Evaluating the Safety and Efficacy of Two Regimens of Danazol Administered Intravaginally for Three Months in Women with Moderate to Severe Pain Associated with Endometriosis

• 12/06
  Third Wave Technologies-A multi-Center Prospective Clinical Study to Evaluate the Performance and Clinical Predictive Value of the Invader HPV HR Molecular Assay and Invader HPV 16/18 Molecular Assay for the Detection of Human Papillomavirus in Cervical Cytology Samples.

• 11/06
  Warner Chilcott- Open-label study of the Safety and Efficacy of a New Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol.

• 8/06-7/07
  Duramed Research-A Prospective, Multi-center, Open-Label study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

• 7/06
  Organon USA, INC-A Randomized, Open-Label, Comparative, Multi-Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive compared to a Monophasic COC.

• 7/06-7/07
  Duramed Research-A Randomized, Multi-center, Double-blind, Placebo-controlled trial to compare the effects of 12 weeks of Treatment with DR-2041 Vaginal Cream vs. Placebo Vaginal cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women.

• 2/06-11/06
  Wyeth Research- A double-blind, randomized, placebo and active controlled efficacy and safety study of Bazedoxifene/conjugated estrogens combinations for prevention of endometrial hyperplasia and prevention of osteoporosis in postmenopausal women.

• 3/06-2/07
  Hormos Medical Corporation- Efficacy and Safety of Ospemifene in the treatment if vulvar and vaginal atrophy (VVA) in postmenopausal women: A 12-week randomized, double-blind, placebo-controlled, parallel-group study comparing oral Ospemifene 30 mg and 60 mg daily doses with placebo.

• 11/05 – 2/07
  Neurocrine Biosciences- A phase II, randomized, double-blind, placebo-controlled twice-daily dosing study of NBI-56418 in endometriosis.

• 7/05
  Xanodyne Pharmaceuticals, Inc. A 12 month, open-label, multicenter study to evaluate the safety of a 1.3 gram dose of a new modified-release tranexamic acid formulation administered three times daily as needed for up to 5 days during the menstrual cycle in women with heavy menstrual bleeding associated with Menorrhagia.

• 8/05-5/06
  3M Pharmaceuticals- A randomized, double-blind, placebo controlled, dose response study to evaluate 851B gel delivered intravaginally twice a week for two, three-week cycles in women who are positive for high-risk genotypes of Human Papillomavirus and have mild cytological abnormalities.

• 7/05-2/06
  Wyeth Pharmaceuticals- A phase 3, randomized, double-blind, placebo controlled study to evaluate the effect of Levonorgestrel 90 micrograms and Ethinyl Estradiol 20 micrograms in a continuous daily regimen on cycle-related symptoms (CRS)

• 6/05-6/07
  Duramed Research- A multicenter, open-label study to evaluate the efficacy and safety of an extended cycle, low dose, combination oral contraception regimen, DP3-Lo 84/10, which utilizes Ethinyl Estradiol during the seven day interval between each 84-day cycle of combination therapy for the prevention of pregnancy in women.

• 4/05-5/07
  Novo Nordisk Pharmaceuticals- A 12 month double-blind, randomized, parallel-group, placebo controlled, multi-center trial to investigate the efficacy and safety of Vagifem Low Dose in the treatment of postmenopausal atrophic vaginitis symptoms

• 1/05-11/06
  Duramed Research Inc.-Evaluate the Safety and Efficacy of Oxybutynin Vaginal Ring Releasing 4 Mg/Day versus 6 Mg/Day versus Placebo in Women Diagnosed with Overactive Bladder Who have Symptoms of Predominant or Pure Urge Incontinence, Urgency and Frequency.

• 1/05-3/07
  Duramed Research Inc.-A randomized, multi-center, double-blind study to evaluate extended cycle oral contraceptives compared to conventional therapy for treatment of cyclic pelvic pain in woman.

• 7/04-8/05
  Upsher-Smith Laboratories- Placebo-controlled, randomized, double-blind, multicenter study, to determine the efficacy of 12 weeks of treatment with USL-221 on moderate to severe vasomotor symptoms and vulvar/vaginal atrophy in postmenopausal patients.

• 5/04-6/05
  Ortho McNeil, Inc. CAPSS-320- Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCI Transdermal System Versus Morphine IV Pump for Pain Management after Non-emergent Lower Abdominal or Pelvic Surgery.

• 5/04-1/05
  Eli Lilly and Company H3S-US-GGKO- Raloxifene Alendronate Comparison in Postmenopausal Women with Low Bone Mass. Study closed per sponsor.

• 4/05-02-06
  ETHICON, Inc 2003-014 A Randomized, multi-center study to evaluate the clinical performance of high viscosity DERMABOND topical skin adhesive in comparison to commercially available sutures for perineal repair following childbirth.

• 03/04-3/8/05
  Ortho-McNeil CAPSS-300- The effect of Ditropan XL on Vasomotor symptoms in healthy post-menopausal women: A double-blind placebo controlled pilot study.

• 03/04-7/05
  Barrier Therapeutics BT0300C1-300-USA- A multi-center, randomized, double-blind, comparative, safety and efficacy study of a Single Dose of 400 mg Itraconazole given as two 200 mg Film-coated tablets versus a single dose of 150 mg Fluconazole given as a single tablet in the treatment of vaginal candidiasis.

• 01/04-9/05
  Lilly F1J-US-SBCD Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-morbidities with Stress Urinary Incontinence: Evaluation of Efficacy and Safety.

• 09/03-03/06
  Lilly F1J-MC-SBBO Efficacy and Safety of Duloxetine Compared with Placebo in Women with Symptoms of Mixed Urinary Incontinence.

• 04/04-11/06
  TAP Pharmaceuticals C03-062 A Phase 3, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects with Uterine Leiomyomata.

• 07/03-1/5/05
  TAP Pharmaceuticals C02-037 A Phase 3, Multi-center, 6-month, Randomized, Double-blind Study to evaluate the Safety of Two Doses of Asoprisnil in Subjects with Uterine Leiomyomata.

• 07/03-02/04
  Johnson & Johnson CA-P-2296-2 An Investigator Blinded, Parallel Group Study to Compare the Safety, Therapeutic Efficacy, and Vulvovaginal Symptomatic Relief of Miconazole Nitrate 16% (600mg) Vaginal Ointment Plus Miconazole Nitrate (2%) External Vulvar Cream to MONISTAT 7 Vaginal Cream (Miconazole Nitrate 2%) in the Treatment of Vulvovaginal Candidiasis.

• 01/03-10/04
  Wyeth 0858A2-313-NA A Phase 3, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90ug and Ethinyl Estradiol 20ug in a Continuous Daily Regimen for Oral Contraception.

• 04/03-09/04
  TAP Pharmaceuticals M02-408 A Phase 2, 12-Month, Open-label Extension Study to Evaluate the Safety of J867 (5mg QD) in Subjects with Endometriosis.

• 6/02-04/03
  TAP Pharmaceuticals M01-398 A phase II, 3 month randomized, double blind study to evaluate efficacy and safety of three doses of J867 vs. placebo in subjects with endometriosis.

• 10/03-8/05
  TAP Pharmaceuticals M01-391 A phase III, 12-Month, extension study to evaluate the safety of Asoprisnil in subjects with Uterine Leiomyomata.

• 6/02-03/04
  TAP Pharmaceuticals M01-390 A phase III, 12 month, randomized, double blind study to evaluate the efficacy and safety of two doses of J867 vs. placebo in subjects with uterine leiomyomata.

• 6/02-8/06
  Novartis ZOL446H A multicenter, double blind, randomized, placebo-controlled study to evaluate the safety and efficacy of Zoledronic acid in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D.

• 5/02-12/03
  Wyeth 0713x1- 013 A Prospective, double blind, placebo-controlled study of Premarin Vaginal Cream/Premarin 0.45 plus MPA 1.5 mg in the treatment of postmenopausal women with dyspareunia.

• 11/01-12/02
  SFBC Charlotte TCR-03 A multi-center, double blind, parallel group study comparing the bioequivalence of TEVA Pharmaceutical’s USA’s generic formulation of Metronidazole Vaginal Gel, 0.75% and Metro-Gel-Vaginal Metronidazole Vaginal Gel, 0.75% in the treatment of Bacterial Vaginosis.

• 10/01-03/03
  Lilly F1J-MC-SBBA Prospective outcomes of Duloxitene in usual naturalistic care in women with stress urinary incontinence.

• 10/01-03/02
  Ross Products CB-83 Use of the Fetal Fibronectin (fFN) test in pregnant women experiencing symptoms of pre-term labor- an outcomes registry.

• 10/01-12/03
  Sepracor Inc.- 332-151 Open-label extensions study of Sustained Release (S)-Oxybutynin in subjects with symptoms of overactive bladder.

• 7/01-12/02
  Sepracor Inc. - 332-146 A double blind, placebo-controlled study of Sustained Release (S)-Oxybutynin in subjects with symptoms of overactive bladder of urgency, frequency and urinary incontinence.

• 2/01-6/02
  Ortho-McNeil CAPPS-153 A multi-center, randomized, open label, parallel group study to evaluate the endometrial safety following treatment with Ortho-Prefest compared to Prempro in postmenopausal women.

• 5/00-12/01
  Organon 147-001 A randomized open label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety & acceptability of monophasic OC’s containing 200 ug org 30659 and 20 ug EE, compared to OC’s containing 100 ug levonorgestrol and 20ug EE.

• 8/99-12/99
  RPR 106522-602 A double blind randomized trial in postmenopausal women receiving HRT (Combipatch vs. Prempro).

• 1988
  Squibb Nystatin vs. Placebo in vaginal moniliasis

Staff Expertise

Erin M. Obermeier, CCRP, CCRC
Clinical Research Coordinator
8 years experience in clinical research

Barbara Brown, RN
Clinical Research Coordinator
7 years experience in clinical research

Patient Demographics

Our age related patient mix is about 33% younger than 35 years old, 33% 35-50 and 33% over 50 years old (i.e. menopausal). Approximately 40% of our patients are Caucasian, 40% African American, and 20% are Hispanic or from other ethnic groups. Most of our patients are lower middle to upper middle class. Over 2/3 of our patients are workingwomen. Our total patient pool from chart racks and computer database totals in excess of 40,000 patients.

Other Information

Additional Web Site - www.phoenixobgyn.com

Contact Information

Bruce J. Levine, M.D., F.A.C.O.G.
Principle Investigator
Phoenix Ob Gyn Associates, L.L.C.
110 Marter Avenue, Suite 505
Moorestown, NJ 08057
USA
Phone: 856-235-4341
Fax: 856-235-6939
EMail: Phoenixstudies@phoenixobgyn.com
Web Site: http://www.phoenixobgyn.com

Currently Enrolling Trials

• Female Overactive Bladder Study

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.