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(1) FERTILITY
Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Hornberger K, Scharf ES.
Treating fallopian tube occlusion with a manual pelvic physical therapy. Alternative
Therapies in Health and Medicine. 2008 Jan-Feb;14(1):18–23.
Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating
female infertility and improving IVF pregnancy rates with a manual physical therapy
technique. Medscape General Medicine. 2004;6(2):51.
(2) MENOPAUSE AND OSTEOPOROSIS
Hormone Replacement Therapy
ClinTrials Research Inc./TheraTech, Inc. Comparison of Two Doses of an Estradiol
Matrix Transdermal Delivery System (EMTDS) with Placebo Matrix Transdermal
Delivery System I in the Treatment of Women with Postmenopausal Symptom, 1994.
Mead Johnson Laboratories: Evaluation of the Effect of the 0.5 mg
Estrace Compared to Placebo on Biochemical Markers of Bone
Resorption in Postmenopausal Women, 1994.
Novo Nordisk Pharmaceuticals, Inc.: Evaluation of Estrofem® 0.25, 0.5,
1.0, and 2.0 mg on Relief of Vasomotor and Other Symptoms of the
Menopause, 1993.
Solvay Pharmaceuticals, Inc.: Study of Estrafied Estrogens Plus Methyltesterone
(Estratest®) and Esterified Estrogens (Estratab® 1.25 mg) in Surgically Postmenopausal
Women: symptoms, psychometric assessments, serum and saliva hormone levels, 1993.
Kabi Pharmacia: Comparison of a Continuous Low Dose of Estradiol
Released from a Vaginal Ring vs. Conjugated Equine Estrogen in a
Vaginal Cream in the Treatment of Postmenopausal Women with Signs
and Symptoms of Urogenital Atrophy, 1992.
Solvay Pharmaceuticals, Inc.: Investigation of Three Doses of Esterifield
Estrogens (Estratab®) on Bone Mineral Density and Parameters of Bone
Metabolism in Postmenopausal Women, 1992.
Solvay Pharmaceuticals, Inc.: Study of the Effects of Estratest H.S.®,
Estratest®, and Premarin® in Surgically Menopausal Women, 1992.
Zeneca Pharmaceuticals Group: Comparison of 3.6 mg ZOLADEX
therapy with or without hormone replacement therapy for the treatment of
endometriosis, 1992.
2
Hormone Replacement Therapy—Protocols
Berlex Laboratories, Inc. (Protocol 96097). A Multicenter, Double-Blind, Randomized
Comparison of Continuous Oral Estradiol-Drospirnone Combinations and Continuous
Oral Estradiol: examining the effects on the endometrium, symptoms, and bleeding
patterns in postmenopausal women.
ClinTrials Research, Inc. TheraTech, Inc. (Protocol E94001A). An Open-Label,
Multicenter Extension of Protocol No. E94001 to Describe the Use of Two Doses of an
Estradiol Matrix Transdermal Delivery System (EMTDS) in the Treatment of Women
with Postmenopausal Symptoms.
Eli Lilly & Company (Protocol H3S-MC-GGHG). Comparison of Raloxifene HCl,
Estrogen and Placebo on the Uterus in Healthy Postmenopausal Women.
Eli Lilly & Company (Protocol H3S-MC-GGHD). Comparison of Raloxifene HCL,
Continuous Combined Hormone Replacement Therapy and Placebo in Early
Postmenopausal Women: once a week Estradiol-Levonorgestrel combination transdermal
system (TDS).
Ethical Pharmaceuticals (UK) Ltd. (Protocol EPCOUS02). A Clinical Evaluation of the
Effects of Estradiol TD and Combi TD, Used Continuously, on Estradiol-Induced
Endometrial Hyperplasia.
Novo Nordisk Pharmaceuticals, Inc. (Protocol VAG/PD/9/USA). A Randomized,
Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study Comparing the
Efficacy and safety of Vagifem 10 μg and 25 μg doses in Treatment of Estrogen
Deficiency Derived Atrophic Vaginitis.
Novo Nordisk Pharmaceuticals, Inc. (Protocol KLIM/PD/7/USA). A Double-Blind,
Randomized, Parallel Group, Multicenter, Dose Finding Study Comparing the Efficacy
and Safety of 1 mg 17β-Estradiol in Combination with Low Doses of Norethindrone
Acetate with that of 1 mg 17β-Estradiol Alone on the Endometrium in Postmenopausal
Women.
Novo Nordisk Pharmaceuticals, Inc. (Protocol KLIM/USA/1/USA). Bleeding Profile
with Continuous Combined Hormone Replacement Therapy: A randomized, double-
blind, multicenter, comparative trial of 1 mg 17B-Estradiol in combination with 0.25 mg
or 0.5 mg Norethindrone Acetate and Prempro®.
Ostex International, Inc. (Protocol OST-C2). A Study of the Use of Osteomark in the
Quantitation of Cross-Linked N-telopeptides of a Type I Collagen as an Aid in
Monitoring the Effect of Therapies Used for the Prevention and Management of Bone
Loss in Postmenopausal Women.
Procter & Gamble Pharmaceuticals (Protocol 1996023). A Randomized, Double-Blind,
Placebo-Controlled 24 Month, Dose Ranging, Multicenter Study Protocol Comparing
3
EMTDS to Placebo in the Prevention of Bone Loss in Hysterectomized Postmenopausal
Women.
Procter & Gamble Pharmaceuticals/TheraTech (Protocol 1998049). A 12-week,
Randomized, Parallel Group, Multicenter, Wear Study to Assess Skin Tolerance with a
40-Week Safety Extension Period Comparing Three Continuous Dose Regimens (0.1,
0.2, and 0.4 mg/day NETA Combined with 0.05 mg/day Estradiol) under Conditions of
Routine Clinical Use.
Rhone-Poulace Rorer (Protocol RPR 106522-303). A Randomized, Double-Blind,
Multicenter, Placebo-Controlled, Menopausal Symptom Study of Three Doses of RPR
Estradiol Norethisterone Acetate (NETA) Patches in a Sequential Wear Hormone
Replacement Therapy (HRT) Regimen.
R.W. Johnson PRI (Protocol ESTNRG-CHRT-102). A Multicenter, Randomized,
Double-Blind, Parallel Group, Dose-Ranging Study to Evaluate the Safety of a
Cyclophasic Hormone Replacement Therapy Regimen of Estradiol and Norgestimate and
its Effects on Endometrial Histology, Vaginal Bleeding and Metabolic Parameters in
Postmenopausal Women.
R.W. Johnson (Protocol ESTNRG-CHRT-104). A Multicenter, Double-Blind,
Randomized Parallel Group, Placebo-Controlled Study to Evaluate the Safety and
Efficacy of Oral 17β-Estradiol for the Treatment of Vasomotor Symptoms and Genital
Atrophy in Postmenopausal Women.
RW Johnson Pharmaceuticals Research Institute (Protocol ESTRNG-CHRT-106). A
Multicenter, Randomized, Double-Blind Exploratory Study Investigating the
Pharmacodynamic Profile of Two Different Hormone Replacement Therapy Regimens:
conjugated estrogens plus Medroxyprogesterone Acetate vs. Micronized Estradiol plus
cyclophasic addition of Norgestimate (Cyclophasic HRT) vs. Placebo in postmenopausal
women.
Sterling Winthrop Pharmaceuticals (Protocol SR41319B-004). A Phase III Study of
Intermittent Cyclical Tiludronate in the Treatment of Established Post-Menopausal
Osteoporosis.
The Upjohn Company (Protocol M5410/0336). Evaluation of Endometrial Histology and
Bone Mineral Density (BMD) in Postmenopausal Women Receiving OGEN/PROVERA)
Hormone Replacement Therapy (HRT).
Wyeth-Ayerst Research (Protocol 0802D1-324-US). A Randomized, Double-Blind,
Placebo- and Active-Controlled, Parallel, Multicenter Study to Assess the Safety and
Efficacy of 3 ½ Day Combinations of 17β-Estradiol/Norethindrone Acetate Transdermal
Delivery Systems for Relief of Menopausal Vasomotor Symptoms and Reduction of
Endometrial Hyperplasia.
4
Osteoporosis
Mead Johnson Laboratories: Evaluation of the Effect of the 0.5 mg Estrace Compared to
Placebo on Biochemical Markers of Bone Resorption in Postmenopausal Women, 1994.
Solvay Pharmaceuticals, Inc.: Investigation of Three Doses of Esterifield Estrogens
(Estratab®) on Bone Mineral Density and Parameters of Bone Metabolism in
Postmenopausal Women, 1992.
Osteoporosis Protocols
Boehringer Manheim Pharmaceuticals Corporation (Protocol MF4380). Double-Blind,
Placebo-Controlled, Randomized, Multicenter Study on the Efficacy and Safety of
Ibandronate (BM 21.0955) during Three Years Treatment in Patients with
Postmenopausal Osteoporosis Using an Intermittent (every 3 months) I.V. Injection
Regimen of 1 mg.
Eli Lilly & Company (Protocol H3S-MC-GGGK). Comparison of Raloxifene HCl and
Placebo in the Treatment of Postmenopausal Women with Osteoporosis.
Eli Lilly & Company (Protocol H3S-MC-GGHF).Raloxifene HCl versus Placebo versus
Hormone Replacement Therapy: Histomorphologic Effects in Bone Loss.
Novo Nordisk Pharmaceuticals, Inc. (Protocol LEV/PD/15/USA). A Double-Blind,
Randomized Placebo-Controlled Trial of Three Doses of Levomeloxifene and Prempro®
for the Prevention of Postmenopausal Osteoporosis.
Novo Nordisk Pharmaceuticals, Inc. (Protocol LEV/PD/16/USA). A Double Blind,
Randomized, Multicenter, Placebo-Controlled Trial of 1.25 and 2.5 mg of
Levormeloxifene for the Treatment of Postmenopausal Osteoporosis.
Novo Nordisk Pharmaceuticals, Inc. (Protocol LEV/PD/17/USA). A Double-Blind,
Placebo-Controlled Trial to Study the Safety and Efficacy of 2.5, 10, and 40 mg of
Levormeloxifene for the Prevention of Postmenopausal Bone Loss.
Organon, Inc. (Protocol 010-006). A Dose-Finding Efficacy & Safety Study of Tibolone
(Org OD 14) for Prevention of Osteoporosis in Postmenopausal Women.
Ostex International, Inc. (Protocol OST-C2). A Study of the Use of Osteomark in the
Quantitation of Cross-Linked N-telopeptides of a Type I Collagen as an Aid in
Monitoring the Effect of Therapies Used for the Prevention and Management of Bone
Loss in Postmenopausal Women.
Pfizer, Inc. (Protocol 174-106). A Randomized, Double-Blind, Placebo-Controlled Study
of the Effects of Droloxifene 40 mg/d, 60 mg/d, and 80 mg/d on BMD in Osteopenic,
Postmenopausal Women.
5
Pfizer, Inc. (Protocol 174-113). A Study of the Safety and Efficacy of Droloxifene for
Preventing Bone Loss in Normal, Early Postmenopausal Women.
Pfizer, Inc. (Protocol A2181003-5045). A Study of the Safety and Efficacy of
Lasofoxifene for the Prevention of Bone Loss and for Lipid Lowering in Postmenopausal
Women at Risk for Osteoporosis.
Procter & Gamble Pharmaceuticals/G.H. Besselaar Associates (Protocol RPE 002494). A
Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to
Compare the Efficacy and Safety of Risedronate (NE-58095) plus Estrogen versus
Estrogen Only in the Prevention of Bone Mineral Mass and No Vertebral Fractures.
Procter & Gamble Pharmaceuticals/G.H. Besselaar Associates (Protocol RVN008993). A
Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to
Determine the Efficacy and Safety of Risedronate (NE-58095) in the Treatment of
Postmenopausal Women with Established Osteoporosis-Related Vertebral Deformities.
Procter & Gamble Pharmaceuticals / Quintiles Inc. (Protocol RHN009193). A
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to
Determine the Efficacy and Safety of Risedronate in the Treatment of Osteoporosis in
Elderly Women.
Procter & Gamble Pharmaceuticals (Protocol 1996023). A Randomized, Double-Blind,
Placebo-Controlled 24 Month, Dose Ranging , Multicenter Study Protocol Comparing
EMTDS to Placebo in the Prevention of Bone Loss in Hysterectomized Postmenopausal
Women.
Roche Pharmaceuticals (Protocol MF4492). Double-Blind, Placebo-Controlled,
Randomized, Multicenter Study on the Efficacy and Safety of Ibandronate During an
Extended Two Year Partial Crossover Study of Patients Enrolled in MF4380 Using an
Intermittent I.V. Injection Regimen of 0.5 mg and 1 mg Every 3 Months.
Sterling Winthrop Pharmaceuticals (Protocol SR 41319B-005). A Phase III Study of
Intermittent Cyclical Tiludronate in the Treatment of Post-Menopausal Women with Low
Bone Mineral Mass and no Vertebral Fractures.
Sterling Winthrop Pharmaceuticals (Protocol SR41319B-004). A Phase III Study of
Intermittent Cyclical Tiludronate in the Treatment of Established Post-Menopausal
Osteoporosis.
The Upjohn Company (Protocol M5410/0336). Evaluation of Endometrial Histology and
Bone Mineral Density (BMD) in Postmenopausal Women Receiving Ogen/Provera)
Hormone Replacement Therapy (HRT).
6
(3) GYNECOLOGICAL/UROLOGICAL CONDITIONS
Candidiasis
Bayer Corporation (Protocol S95-003). A Multicenter, Prospective, Randomized, Single-
Blind, Parallel-Group Comparison of the Clotrimazole 1-Day (One 500 mg Vaginal
Insert) and the Clotrimazole 3-Day Regimens (One 200 mg Vaginal Insert Daily for 3
Days) with Clotrimazole 7-Day Regimen (One 100 mg Vaginal Insert Daily for 7 Days)
for the Treatment of Vulvovaginal Candidiasis.
Advance Care Products, Ortho Pharmaceutical Corporaqtion (Protocol 94-007P). Phase
III Study Comparing Micanzole Nitrate (4%) Vaginal Cream and Mixanozole Nitrate
(2.8%) Vaginal Cream to Monistat® 7 (2%) Vaginal Cream in the Treatment of
Vulvovaginal Candidiasis.
Endometriosis
IBAH / Searle Research and Development (Protocol N65-97-02-001). Clinical Protocol
for a Dosing Optimization Study of Syneral® for Endometriosis: Safety and Efficacy of a
Single 400μG Daily Dose for 6 Months and a Step-Down Dose from 200μG BID for 2
Months to 200μG Daily for 4 Months: a double-blind, placebo-controlled, randomized
comparison to the currently recommended regimen of 200μG BID daily for 6 months,
IND # 18,138.
Oral Contraceptives
Organon, Inc./Pharmaco LSR (Protocol 086-001). An Open Label, Multicenter, Non-
Comparative Safety and Efficacy Study of the Desogestrel Containing Oral Contraceptive
CTR 25.
Organon, Inc./Pharmaco LSR (Protocol 092-001).An Open-Label, Randomized, Parallel,
Comparative, Multicenter, Safety and Efficacy Study of Triphasic Combination Oral
Contraceptives, CTR 99 and CTR 77, versus Ortho-Novum 777.
Organon, Inc./Quintiles, Inc. (Protocol 069-001). An Open-Label Noncomparative
Efficacy and Safety Study of Implanon, a one-Rod Contraceptive Implant Containing 3-
Ketodesogestrel in Healthy Female Volunteers, with Subsets for Pharmacokinetic
Measurements, Ophthalmological Assessments, Carbohydrate Metabolism, Lipid
Metabolism and Endometrial Morphology.
Organon, Inc. (Protocol 147-001). A Randomized, Open-Label, Comparative,
Multicenter Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and
Acceptability of a Monophasic COC Containing 200μg EE, Compared to a COC
Containing 100μg Levonorgestrel and 20μg EE.
Ortho-McNeil Pharmaceutical (Protocol CAPSS022). A Comparison of Two Oral
Contraceptives: Oral Tri-Cyclen® vs. Loestrin® Fe 1/20.
7
RW Johnson Pharmaceutical Research Institute (Protocol NRGEEP-CONT-004). An
Open-Label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal
Contraceptive System of 17-Deacetylnorgestimate and Ethinyl Estradiol with the Oral
Contraceptive Triphasil.
Overactive Bladder and Urinary Incontinence
Eli Lilly & Company (Protocol H3S-MC-SAAL). Duloxetine versus Oxybutnin in
Patients with Urge Incontinence: A Multiple-Dose Study for Efficacy and Safety.
Pharmacia & Upjohn Pharmaceuticals (Protocol 97 OATA 039). Dose Escalation Study
with Tolterodine in Patients with Overactive Bladder: a single-blind study in patients
with symptoms of overactive bladder including urinary urgency and frequency with or
without urge incontinence.
Pharmacia & Upjohn Pharmaceuticals (Protocol 98-TOCR-007). Long-Term Safety and
Efficacy of Tolterodine Prolonged Release Capsules: an open-label, uncontrolled,
multinational study in patients with symptoms of overactive bladder.
Pharmacia & Upjohn Pharmaceuticals (Protocol 98-TOCR-007B). Long-Term Safety and
Efficacy of Tolterodine Prolonged Release Capsules: an open-label, uncontrolled,
multinational study in patients with symptoms of overactive bladder.
Urinary Tract Infection
Bayer (Protocol 100398). Prospective, Randomized, Double-Blind, Multicenter,
Comparative Trial to Evaluate the Efficacy and Safety of Ciprofloxacin Once Daily
Extended Release 500mg Tablets QD for 3 Days versus Conventional Ciprofloxacin
250mg Tablets BID for 3 Days in the Treatment of Patients with Uncomplicated Urinary
Tract Infections.
(4) MISCELLANEOUS SUBJECTS. Other areas of investigation include the
following:
Arthritis
GD Searle & Company (Protocol N49-98-02-102). Clinical Protocol for a Multicenter,
Double-Blind, Parallel Group Study Comparing the Incidence of Clinically Significant
Upper Gastrointestinal Adverse Events Associated with SC-58635 400 mg BID to that of
Diclofenac 75 mg BID in Patients with Osteoarthritis or Rheumatoid Arthritis, IND #
48,395.
Merck Industries (Protocol 088-001). A Double-Blind, Randomized, Stratified, Parallel-
Group Study to Assess the Incidence of PUB’s During Chronic Treatment with MK-0966
or Naproxen in Patients with Rheumatoid Arthritis.
8
Chronic Bronchitis
Abbott Laboratories, Inc. (Protocol M97-766). Comparative Study of the Efficacy of
Clarithromycin and Azithromycin for the Treatment of Patients with Acute Exacerbation
of Chronic Bronchitis.
Community Acquired Pneumonia
Abbott Laboratories, Inc. (Protocol M98-939). Comparison of the Safety of
Clarithromycin IR (250 mg) BID to Levofloxacin (500 mg OD) for the Treatment of
Community-Acquired Pneumonia.
TAP Holdings (Protocol CEF-97-002) A Comparative Study on the Safety and Efficacy
of Cefditoren Pivoxil and Cefpodoxime Proxetil in the Treatment of Community-
Acquired Pneumonia.
Diabetes
Bristol-Myers Squibb/US Pharmaceuticals (Protocol CV 138-002). Comparative
Outcomes Study of Metformin Intervention versus Conventional Approach: the cosmic
approach study.
Insmed Pharmaceuticals (Protocol INS1-DM-28). A Randomized, Multicenter, Double-
Blind, Parallel-Group Clinical Study to Compare the Effects of INS1 (D-Chiro-Inositol)
versus Placebo as Initial Oral Therapy in Subjects with Type 2 Diabetes Mellitus who
Fail to Achieve Adequate Glycemic Control with Diet and Exercise Alone.
Hypertension
ALLHAT National Trial on Hypertension Agents and Heart Disease. 5-year NIH trial.
GD Searle & Company (Protocol IE3-98-02-01). A Double-Blind, Placebo-Controlled,
Randomized Study to Evaluate the Safety and Efficacy of Ranging Doses of Eplernone
Relative to Placebo, Hydrochlorothiazide and Daily Dose Combinations of Eplernone
and Hydrochlorothiazide for the Treatment of Mild to Moderate Hypertension.
Lipid Lowering
Pharmacia Corporation (Protocol NB4-00-02-009). Clinical Protocol for a Randomized,
Double-blind, Placebo-controlled Study of SD-5613 as Monotherapy in Patients with
Primary Hypercholesterolemia (Monotherapy) Assessment of Reducing Cholesterol
[MONARCH]), IND #58,482.
9
Migraine
GlaxoWelcome. Imitrex Injection in the Treatment of Acute Migraine and Cluster
Migraine.
GlaxoWelcome. Imitrex Injection vs. Imitrex Tablets in Chronic Severe Migraine.
Wyeth-Ayerst. Inderol LA in Chronic Severe Migraine: Inderol LA 160mg vs. Inderol
40mg TID vs. Calcium Channel Blocker.
Sinusitis
Abbott Laboratories (Protocol M00-225). Comparative Study of the Safety and Efficacy
of ABT-773 150 mg QD vs. 150 mg BID for the Treatment of Acute Bacterial Sinusitis.
F
UNDED RESEARCH SUPPORT
Miles, Inc.Clotrimazole 2% Vaginal Cream, 1993
Wyeth-Ayerst Laboratories. Trigonitis, 1992
SmithKline Beecham. Paxil, Carvedelol, Asthma, Arthritis, 1990-1991
3M/Bio: Pharm Estradiol Patch Study, 1990
Health & Sciences Research, Inc. Noven Patch Study, 1990
Organon, Inc. Desogestrel O.C. CTR-04 Study, 1990
Bartor. Estrapel and Effects of Estradiol Production Levels, 1989
Columbia Laboratories, Inc. Vaginal Moisturizing Gel Study, 1989
NIH (Co-Investigator with Dan Martin, Ph.D.). Walking and Bone Mass, 1988–1990
Ayerst. Estrogen, Exercise and Lipid Study, 1988–1990
Reid-Rowell. Estratab and Estratest and Effects on Lipids and Bone Mass, 1988–1990
Wallace Laboratories, 1987–1990
Felbamate Development Program for Lennox Gasteau Syndrome, Seizures
Organidin Reformulation Studies – cough /cold
10
Ciba-Geigy. Opthalmologics, Antihypertensives, 1983-1984
Nautilus, Inc. Exercise Physiology and Osteoporosis, 1982-1990
Ayerst Laboratories, 1982–1986
Altromid-S Protocols
Inderal – Product Line Extension Hypertension
Effexor – Antidepressant Study Program
Lodine Development RA, OA Protocols
PremPro Development Plan and Protocols
Premarin Osteoporosis Program Development
Prem Phase Development Plan and Protocols
Various Oral Contraceptive Studies
Ayerst Laboratories. Premarin, GNRH, 1982
SmithKline Beecham, 1981–1984
Diagnostic Bioequivalence Studies and Reformation
Monoacid Injectable Antibiotic Development Protocols
Paxil Antidepressant Studies UK and US
Obsessive Compulsive Studies US
Relafen Full Development Plan and All Protocols
RA and OA; Pain
Pharmacokinetic Studies
Ridawra – OA and RA Study Program
Topical Use Eczema Program
Tagamet – Ulcer Peptic and Gastric Studies
Various Ophthalmologics Topical – Antibiotics, Steroids
Schering Laboratories. Topical and Transdermal Delivery Systems, 1981-1982
Upjohn Laboratories. Depression, Hypertension, 1981-1983
Note: Additional sources of Funded Research Support include: Ayerst Laboratories, 1987;
Abbott Laboratories, 1986; Florida Department of Health and Rehabilitative Services III, 1986;
Lederle Laboratories, 1986; Nuclear Data, 1985-1986; Ayerst Laboratories, 1985; Wyeth
Laboratories, 1985; Bruner Foundation, 1983–1985; FL Dept. of Health & Rehabilitative
Services I, 1983; FL Dept. of Health & Rehabilitative Services II, 1983–1984; and Schering
Laboratories, 1983–1984.