Clinical Research

Principal Investigator

Efficacy and Safety Comparison of Estrogel (17β-estradiol in a topical gel) and the Climara Patch 12.5 sq cm System in the Treatment of Women with Menopausal Symptoms.
Study No. CV141-002
Bristol-Myers

A randomized, double-blind, placebo and active-controlled, parallel, multicenter study to assess the safety and efficacy of 3-day combinations of 17β Estradiol/Norethindrone Acetate ransdermal delivery systems for relief of menopausal vasomotor symptoms and reduction of endometrial hyperplasia.
Study No. 0802DI-324-US
Wyeth-Ayerst Research.

Multicenter dose-finding study comparing the efficacy of EMD 90 171, once- a-week estradiol-levonorgestrel combination transdermal system (TDS), with placebo in the treatment of vasomotor symptomsassociated with menopause.
Protocol No. EMD 90 171-002
Merck/Lipha

“Multicenter efficacy study comparing EMD 90-171, a once a week estradiol-levonorgestrel combination transdermal system (15cm21% Estradiol/1% Levonorgestrel TDS, 15cm2 1% Estradiol/0.35% Levonorgestrel TDS), with placebo in the treatment of vasomotor symptoms associated with menopause”.
Protocol # S163003
Solvay Pharmaceuticals, Inc.

Teriparatide Compared with Alendronate on Spine Bone Mineral Density in Postmenopausal Women with Osteoporosis.
Protocol B3D-MC-GHBM
Eli-Lilly and Company.

Raloxifene Alendronate Comaprison in Postmenopausal Women With osteoporosis.
Protocol H3S-US-GGKO
Eli Lilly and Company

A Phase III multinational, randomized, double-blind, parallel-group, placebo controlled 24 week study to evaluate the efficacy and safety of transdermal testosterone (300 ug/day) in naturally menopausal women with Hypoactive Sexual Desire Disorder on concurrent oral hormone therapy.
Study no. 2002006
Proctor and Gamble Pharmaceuticals, Inc.

Teripatide (rDNA origin) Injection (LY333334)
FORTEO Observational Study
Eli Lilly and Company B3D-US-GHCQ

A Multi-center, double-blind study to determine the efficacy of ESTRATEST H.S. tablets in relieving menopausal symptoms in estrogenized postmenopausal women.
Solvay Women’s Health Program
Protocol # S0302106
Solvay Pharmaceuticals

A Multi-center, double-blind study to determine the efficacy of ESTRATEST tablets in relieving menopausal symptoms in estrogenized, non-hysterectomized postmenopausal women.
Solvay Women’s Health Program
Protocol # S0302107
Solvay Pharmaceuticals

A Multi-center, double-blind study to determine the efficacy of ESTRATEST tablets in relieving menopausal symptoms in estrogenized, hysterectomized postmenopausal women.
Solvay Women’s Health Program
Protocol # S0302110
Solvay Pharmaceuticals

Efficacy study comparing 0.9 g and 1.25 g EstroGel ® 0.03% doses with placebo in the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause.

Evaluation of safety and efficacy of PROMETRIUM® capsules in induction of secretory conversion of endometrium and withdrawal bleeding in subjects with secondary amenorrhea.

A twenty four week, randomized, double blind, placebo controlled safety and efficacy trial of flibanserin 50 milligrams daily and with uptitration100 milligrams daily in premenopausal women with hypoactive sexual desire disorder.
Boehringer Ingleheim
Protocol 511.75

A twelve month, open label, safety trial of Flibanserin 50 milligrams to 100 milligrams daily in women with hypoactive sexual desire disorder.
Boehringer Ingleheim Pharmaceuticals, Inc
Protocol 511.84

A randomized, double blind, placebo-controlled, multicenter, 52 week study to caluate the endometrial safety of transdermal testosterone (300 mcg/day) in turally postmenopausal women with hypoactive sexual desire disorder.
Proctor and Gamble
Protocol 2007004

Teriparatide (rDNA origin) Injection (LY333334).
Eli Lilly
Project # 62665

Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and, with Uptitration, 100 Milligrams Daily in Premenopausal Women with Hypoactive Sexual Desire
Disorder.
Boehringer Ingelheim
Project # 62854

A Twelve Month, Open-Label, Safety Trial of Flibanserin 50 Milligrams to 100 Milligrams Daily in Women with Hypoactive Sexual Disorder.
Boehringer Ingelheim
Project # 62909

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300ncg/day) in Naturally Postmenopausal Women with Hypoactive Sexual Desire Disorder.
Proctor and Gamble
Project # 62908

Co-Investigator

“A phase III, open, randomized, parallel group, multicenter study to compare the
safety and efficacy of recombinant human follicle stimulating hormone (Gonal-F) administered subcutaneously with urinary human follicle stimulating hormone (Metrodin) given intramuscularly to induce ovulation in WHO Group II
anovulatory Iinfertile women”.
Protocol No. 92-054, Study No. 5727.
Serono.

“A randomized, double-blind, multi-center progestin efficacy study of three doses of RPR Estradiol/Norethisterone acetate (NETA) patches in a continuous wear
HRT regimen compared to an Estradiol 50 patch”.
Protocol No. 106522-202.
Rhone Poulenc Roper.

Study comparing the effect of loestrin Fe 1/20 versus Alesse-28 on serum lipids.
Protocol 376-402
October, 1997
Parke-Davis

A multicenter controlled study of Zoladex 10.8 mg 3 month depot plus iron versus sham plus iron for the preoperative management of premenopausal women with iron deficiency anemia due to uterine fibroids.
Study No. 9393IL/0025
Zeneca Pharmaceuticals.

Comparison of raloxifene, estrogen, and placebo HCL in healthy, postmenopausal women.
A parallel randomized placebo controlled double blind study.
Protocol No. H3S-MC-GGHG
Eli Lilly.

“A prospective, double-blind, randomized study of the safety and efficacy of lower doses of premarin and medroxy progesterone acetate postmenopausal women”
Protocol No. 713-B-309-US
Wyeth-Ayerst.