Dr. Gioi N. Smith-Nguyen

SONY DSCDr. Smith-Nguyen is the Principal Investigator at GCCR, and is a board certified OB/GYN physician with over 25 years of clinical practice and over 3 years of experience as a clinical research investigator. He has earned high praises for compassion and quality of work from patients, colleagues, and sponsors alike.

Diplomate American Board of Obstetrics & Gynecology

EDUCATION:

Undergraduate: 1978 – Franklin& Marshall College
Lancaster, Pennsylvania
BA., Cum Laude, Phi Beta Kappa

Medical School: 1983 - Temple University School of Medicine
Philadelphia, Pennsylvania
Honors in Family Practice & OB/GYN

Residency/Internship: 1983-1987  - Temple University School of Medicine
Philadelphia, Pennsylvania
Obstetrics/Gynecology 1987

BOARD CERTIFICATIONS:

Diplomate American Board of Obstetrics and Gynecology. Certificate #26600
Fellow American College of Obstetrics and Gynecology. Certificate #873474
Board Certified in Obstetrics and Gynecology on 12/8/1989

LICENSES:

State of California License: G61280 Exp: 10/31/2014
Drug Enforcement Agency: AS 2859467 Exp: 02/28/2014

PROFESSIONAL POSITIONS:

  • 2008 Present Grossmont Center for Clinical Research: La Mesa, CA
  • Principal Investigator
  • 2007 2008 Medical Center for Clinical Research: San Diego, CA
  • Sub-Investigator
  • 1992 2006 Sharp Rees Stealy Medical Group: La Mesa, CA
  • Physician of Obstetrics and Gynecology
  • 1991 1992 Private Practice: San Diego, CA
  • Gioi N. Smith Nguyen, M.D
  • 1988 1991 Edwards Air Force Base Hospital: Edwards, CA
  • Department Chief of Obstetrics and Gynecology
  • 1987 1988 Edwards Air Force Base Hospital: Edwards, CA
  • Attending Physician of Obstetrics and Gynecology

Dr. Smith-Nguyen’s Clinical Experiences

Since 2007, Dr. Gioi N. Smith-Nguyen had participated in 59 clinical studies, in which he has been Principal Investigator for the last 26 studies. Ninety percents of those studies are women’s health related.

1. A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)- Controlled, 2-Part Clinical Study of the Efficacy and Safety of XXX in Patients with Overactive Bladder. Merck & Co., Inc.

2. A Phase 3, Twelve-Week, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Efficacy and Safety Study of XXX Capsules in the Treatment of Vasomotor Symptoms Associated with Menopause. Noven Therapeutics, LLC.

3. A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of XXX Capsules in the Treatment of Vasomotor Symptoms Associated with Menopause. Noven Therapeutics, LLC

4. Multicenter, randomized, open-label, parallel-group study to evaluate user satisfaction with and tolerability of the low-dose XXX intrauterine delivery system (IUS) with 12 mcg LNG/day initial in vitro release rate (LCS12) in comparison to a combined oral contraceptive containing 30 mcg ethinyl estradiol and 3 mg drospirenone (Yasmin) in young nulliparous and parous women (18-29 years) over 18 months of use. Bayer HealthCare

5. Intended Use Study of the BD SurePath Plus Pap. BD Diagnostics

6. A multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of XXX compared to Placebo for the Management of Menstrually-Related Migraine Headaches. Teva Women’s Health Research, Inc.

7. A Randomized, Single Blind, Placebo Controlled Phase 2 Study to Assess the Safety of XXX for the Treatment of Cervical Intraepithelial Neoplasia Grade 2/3. Advaxis, Inc.

8. An Open-label, Randomized, Parallel Group, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-Dose Oral Contraceptive Containing 0.02 mg XXX and 0.1 mg XXX in a 21 Day Regimen. Agile Therapeutics, Inc.

9. A Multi-Center, Double-Blind, Placebo-Controlled Trail of XXX 60 mg Daily in Female OAB Patients on Multiple Concomitant Medications Refractory to Detrol LA 4mg Daily. Allergan.

10. An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of XXX Transdermal Delivery System. Watson Laboratories, Inc.

11. A twenty-eight week, open-label, safety, extension trail of XXX 100 milligrams daily in premenopausal and naturally postmenopausal women with hypoactive sexual desire disorder in North America. Boehringer Ingelheim International.

12. A twenty-four week, randomized, double-blind, placebo-controlled, safety and efficacy trial of XXX, with up-titration, 100 milligrams administered orally once daily in naturally postmenopausal women with hypoactive sexual desire disorder in North America. Boehringer Ingelheim International.

13. A prospective, Noninterventional Follow-up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received XXX Injection, 250 mg/ml, or Vehicle for the Prevention of Preterm Birth. KV Pharmaceuticals, Inc.

14. A Phase 3B, Multi-Center, Randomized, Double-Blind Study of XXX Injection, 250 mg/ml, Versus Vehicle for the Prevention of Preterm Birth in Women with a Previous Singleton Spontaneous Preterm Delivery. Hologic, Inc.

15. A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of XXX and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females. Dura Med Research Inc.

16. A Multi-center, Double-Blind, Placebo-Controlled Trial of XXX 60 mg Daily Versus Placebo in Obese (BMI>35Kg/M2) Female OAB Patients. Allergan.

17. A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous XXX in Patients with Iron Deficiency Anemia (IDA). Luitpold Pharmaceuticals, Inc.

18. A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Efficacy and Safety of XXX Flexible Dose Regimen in Vulnerable Elderly Patients with Overactive Bladder. Pfizer Inc.

19. Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker. Sequenom, Inc.

20. A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 and 50 mg XXX in the Treatment of Premenopausal Women with Symptomatic Uterine Fibroids. Repros Therapeutics, Inc.

21. A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator XXX in Anemic, Pre-Menopausal Women with Symptomatic Uterine Fibroids Requiring Hysterectomy. Repros Therapeutics, Inc.

22. A Multi-Center, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric XXX vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent. Luitpold Pharmaceutical, Inc.

23. A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous XXX vs. Standard Medical Care in Treating Iron Deficiency Anemia. Luitpold Pharmaceutical, Inc.

24. A multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous XXX vs Standard Medical Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Postpartum Patients. Clarix-Luitpold.

25. A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of XXX Extended Release Tablets in the Treatment of Vasomotor Symptoms in Postmenauposal Women. Depomed, Inc.

26. A Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety and Efficacy of XXX Vaginal Cream in the Treatment of Mixed Bacterial Vaginosis/Vulvovaginal Candidiasis Infections. KV Pharmaceutical

27. Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC alone. Bayer HealthCare Pharmaceuticals Inc.

28. A Phase 2 Dose Finding Study with XXX in Subjects with Recurrent Episodes of Genital Herpes. Astellas Pharma US, Inc.

29. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-Center Study of XXX in OAB Subjects to Evaluate Symptom Bother and Health Related Quality of Life. (VESIcare Investigation of Bother and Quality of Life in subjects with OAB). Astellas Pharma US, Inc.

30. Long-term Safety of XXX 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women without a Uterus: A 52-week open-label Follow-Up to Protocol 15-50310. Hormos Medical Corporation / QuatRx Pharmaceuticals.

31. A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment with XXX Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women. Duramed Research, Inc

32. A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Oral XXX(Drospirenone 0.5 mg, Drospirenone 0.25 mg / 17B-Estradiol 0.5 mg, and 17B-Estradiol 0.3 mg) for the Relief of Moderate to Severe Vastomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks. Bayer HealthCare Pharmaceuticals Inc.

33. Comparison of XXX vs. Placebo in the Treatment of Vasomotor Symptoms in Women Who Have Survived Breast Cancer. The PRIMMUS 2 Study (PRIstiq for Managing Menopause and Understanding Symptoms).Wyeth Research.

34. A Randomized Double-Blind, Placebo-Controlled Study of XXX in the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D). AGI Therapeutics Research Ltd.

35. A randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of XXX in Female Patients with Irritable Bowel Syndrome with Constipation. Dynogen Pharmaceuticals, Inc.

36. A Phase II, Randomized, Placebo-Controlled Study of XXX in Patients with Chronic Idiopathic Constipation. Procter & Gamble Pharmaceuticals.

37. Multi-center, Open-label, Randomized Study to Assess the Safety and Contraceptive efficacy of Two Doses ( in vitro 12 mg / 24 h and 16 mg / 24 h) of the Utra Low Dose XXX Contraceptive Intrauterine systems (LCS) for a Maximum of 3 years in Women 18 to 35 Years of Age. Bayer HealthCare Pharmaceuticals.

38. A Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Active Comparator, Multi-Center Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Two Doses of XXX Administered Orally as Monotherapy for 12 Weeks in Healthy Postmenopausal Women with Moderate to Extremely Severe Vasomotor Symptoms. GlasxoSmithKline (GSK).

39. A Multi-Center, Double-Blind, Randomized, Placebo-Control Study of XXX in the Treatment of High-Grade Cervical Intraepithelial Lesions (CIN2/3) of the Uterine Cervix. MGI Pharma Biologics, Inc.

40. Multi-Center, Nonrandomized, Open-Label Phase 1 Safety Study of XXX and XXX Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects. Nventa Biopharmaceuticals Corporation.

41. A Phase 2, Randomized, Double-Blind, Paralell-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of XXX with 0.4 mg XXX Using Urodynamics in Male Subjects with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) (ISN 905-CL-058) Astellas Pharma, US, Inc.

42. A Pilot Clinical Study to Evaluate the Efficacy of XXX (estradiol vaginal cream, USP, 0.01%) Cream (Warner Chilcott) in the Treatment of the Signs and Symptoms of Atrophic Vaginitis. Novum Pharmaceutical Research Services.

43. Long-Term Safety of 30 mg and 60 mg Oral Daily Doses of XXX in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women with Intact Uterus: A 40-Week Randomized, Double-Blind, Placebo-Control, Follow-Up to Protocol 15-50310. Hormos Medical, Ltd.

44. A Double-Blind, Randomized, Active-Control Study to Evaluate Effects of Drospirenone/Estradiol (XXX) and Medroxyprogesterone acetate/Conjugated Equine Estrogen (XXX) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women with Hypertension. Bayer HealthCare Pharmaceuticals Inc.

45. Open-Label Study of the Safety and Efficacy of a New Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol. Warner Chilcott (US) Inc.

46. A Multi-Center, Randomized, Open-Label, Paralelled Group, Active Control Study to Evaluate the Efficacy and Safety ofXXX as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients with Idiopathic Menorrhagia. Berlex Inc.

47. A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center Study to Evaluate Efficacy and Safety of 0.65 g and 1.3 g Oral Doses of XXX TID Administered During Menstruation for the Treatment of Menorrhagia. Xanodyne Pharmaceuticals, Inc.

48. A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol XXX/XXX Tablets for the Treatment of Dysfunctional Uterine Bleeding. Berlex, Inc.

49. A Phase 3, Randomized, Multi-Center, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral XXX in Subjects with Gout. TAP Pharmaceutical Products Inc.

50. A Phase II, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Efficacy of XXX in Subjects with Endometriosis. Neurocrine Biosciences, Inc.

51. An Open-Label Study of the Contraceptive Efficacy of an Extended Regimen of Norethindrone and Ethinyl Estradiol. Warner Chilcott.

52. A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate XXX for the Management of moderate to severe Endometriosis-Related Non-Menstrual Pelvic Pain. Duramed Research, Inc.

53. A Multi-Center, Randomized, 8-Week Double-Blind Acute Phase Followed by a 6-Month Continuation Phase (Open-Label or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of XXX vs. Escitalopram in Postmenopausal Women with Major Depressive Disorder. Wyeth Research.

54. A Multi-Center, Randomized, Double-Blind Study to Compare the Efficacy and Safety of Patient-Initiated XXX 1000 mg b.i.d x 1 Day to XXX 500 mg b.i.d x 3 Days in Immunocompetent Adults with Recurrent Genital Herpes. Novartis.

55. A Multi-Center, Open-Label, Safety and Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator XXX in Pre-Menopausal Women with Symptomatic Leiomyomata Who Have Previously Complete Study ZPU-003. Repros Therapeutics, Inc.

56. Evaluation of Pharmacodynamic Effects on Ovulation Suppression and Cycle Control of Three Agile Contraceptive Patches Containing Different Doses of Ethynil Estradiol During Three Cycles of Administration. Agile Therapeutics, Inc.

57. A Non-inferiority Comparison of 35 mg Delayed-releaseXXX, Administered Once-weekly Either Before or After Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multi-center, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study. Procter & Gamble Pharmaceuticals, Inc.

58. Cervical Specimens for Assessment of XXX Collection Medium (DCM). Digene Corporation.

59. Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC alone. Bayer HealthCare Pharmaceuticals Inc.