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Clinical Research Trials
The Department of Obstetrics and Gynecology has a very active clinical research program in every subspecialty.In 2007, we established the Women's Health Clinical Research Center under the direction of Dr. Kurt Barnhart.Many faculty membersare trained in epidemiology and biostatistics or public health. There are numerous clinical trials available in reproductive health, contraception,infertility, gynecologic oncology, urogynecology, and obstetrics. The Division of Reproductive Endocrinology and Infertilityhas been amember of the Reproductive Medicine Network since it was established in 1990, and is one of eight centers in the country carrying out large, multi-center trials in the area of male and female infertility, and reproductive disorders. The Division of Gynecologic Oncology participates in the clinical trials sponsored by the Gynecologic Oncology Group (GOG) andin thephase I and II clinical trials in ovarian cancer offered through the Center for Early Detection and Cure of Ovarian Cancer.
Reproductive Research Unit
Pregnancy in Polycystic Ovary Syndrome II: A 20-Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women with Polycystic Ovary Syndrome The purpose of this 5 month double-blind randomized clinical trial is to determine which medication, Clomiphene Citrate (Clomid) or Letrozole (Femara), will most likely result in pregnancy and live birth in women diagnosed with Polycystic Ovary Syndrome (PCOS). University of Pennsylvania is one of seven sites in the Reproductive Medicine Network who will collectively be recruiting 750 women with PCOS who desire pregnancy. Our overall goal is to enroll 105 healthy PCOS patients, with anovulation as their exclusive infertility factor, over the next three years and provide them with free treatment and follow-up. Subjects must be willing to accept randomization to either treatment, 1) Clomiphene Citrate, or 2) Letrozole and treatment will be provided for up to five cycles or 20 weeks, unless pregnancy is achieved first. Pregnant subjects will be followed until viability is confirmed and pregnancy outcome is determined. Principal Investigator: Christos Coutifaris, MD, PhD, Co-Principal Investigator: Kurt Barnhart, MD, MSCE
Population Genetics of Polycysytic Ovarian Syndrome
This is a correlational study of androgen levels and gene identification in a sample of Polycystic Ovarian Syndrome (PCOS) patients and is being conducted at two sites: the University of Pennsylvania and the University of Iowa. The target enrollment for this study is 200 sets of women diagnosed with PCOS and both their biological parents, for a total of 600 subjects from both sites. A cohort of 100 women aged 18-50 with PCOS and their two parents will be recruited through the gynecological clinical practices, particularly Penn Fertility care. All subjects collect and submit a sputum sample for genetic analysis. The major goal of this research project, the identification of genes contributing to PCOS, will provide basic understanding of the genotype-phenotype relationships that contribute to features of PCOS. Knowledge of “PCOS genes” will assist physicians in practicing and assessing responses to interventions that promote fertility, improve insulin sensitivity, and treat other aspects of this disorder. Principal Investigator: Anuja Dokras-Jagasia, MD, PhD
Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women
This open label, two site, clinical randomized trial will assess a trend toward improvement in the live birth rate across 3 arms in 246 obese, infertile women ages 18-40, who have been diagnosed with polycystic ovarian syndrome. Arm A: an intervention to improve insulin sensitivity via lifestyle modification (weight loss and physical activity program); Arm B: an intervention to improve hyperandrogenism via continuous oral contraceptive (OCP) use; and Arm C: an intervention that combines both lifestyle modification with continuous OCP use. The study will include 3 phases covering the continuum from pre-conception to birth. Phase I (a pre-conception intervention x 4 months prior to ovulation induction), Arm A will complete intense lifestyle intervention (sibutramine + meal replacements + lifestyle modification); Arm B will be treated with continuous OCP and Arm C will receive both treatments. Phase II will include up to 4 cycles of ovulation induction with clomiphene citrate. Participants who conceive will be monitored for pregnancy complications in Phase III. The study sites will include Penn State College of Medicine (PSU) in Hershey PA and University of Pennsylvania School of Medicine. Principal Investigators: Richard Legro, MD and Christos Coutifaris, MD PhD, Co-Principal Investigators: Anuja Dokras- Jagasia, MD, PhD, David Sarwer, PhD
Contraceptive Efficacy of C31G Vaginal Gel
A Multicenter, Randomized, Double-Masked, Comparator Study of the Safety and Contraceptive Efficacy of C31G Vaginal Gel Compared to Conceptrol® Vaginal Gel. Healthy women between the ages of 18 and 40 who are in a monogamous relationship are being recruited into this study to use a new spermicide as their primary form of contraception. The safety and efficacy of this product will be observed in women over the course of six menstrual cycles, with a small subset continuing for twelve cycles. The new spermicide, called C31G, differs from those currently on the market in that it does not contain Nonoxynol-9. Subjects are randomized to either C31G or Conceptrol, an approved spermicide already on the market. Penn is also conducting a sub-study in which colposcopic cervical images are taken of a portion of the study group.
Principal Investigator: Kurt Barnhart, MD, MSCE
150/15 NES/EE Vaginal Ring for Contraception
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of 150µg of Nestorone® and 15µg of ethinyl estradiol (150/15 NES/EE CVR). Healthy women, age 18-40, will be recruited into this study to evaluate the safety and contraceptive efficacy of a new contraceptive vaginal ring to be used on a three-weeks-in/ one-week-out regimen, using the same ring for 13 consecutive cycles. Penn is also participating in an endometrial biopsy sub-study to evaluate the effects of this new product on the endometrium.
Principal Investigator: Kurt Barnhart, MD, MSCE
Serum Bank for Assessment of Markers for Ectopic Pregnancy
The purpose of this protocol is to develop a bank of serum specimens for a series of pilot studies and to determine the predictive ability of serum markers to distinguish among normal first trimester pregnancy, early miscarriage, and ectopic pregnancy. The study population is women experiencing vaginal bleeding and/or cramping in early pregnancy. Serum leftover from routine clinical tests is banked so that these markers can be retrospectively measured and correlated with clinical diagnoses.
Principal Investigator: Kurt Barnhart, MD, MSCE
A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate DR-2001 for the Management of Moderate to Severe Endometriosis-Related Nonmenstrual Pelvic Pain
This phase II, three-arm, multicenter, double-blind, randomized, placebo-controlled study is designed to compare the ability of danazol delivered by vaginal ring (DR-2001) at doses of 3 or 7 mg/day to placebo in producing beneficial changes in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period. Women aged 18-45 may be eligible to participate if they have documentation of a previous diagnosis of endometriosis by laparoscopy, laparotomy, and/or histology within five years, and moderate or severe nonmenstrual pelvic pain.
Principal Investigator: Kurt Barnhart, MD, MSCE
In Vitro Fertilization Research
Blood and follicular fluid samples from patients of Penn Fertility Care who are undergoing in vitro fertilization are being collected and analyzed to investigate ways to predict and enhance IVF success rates, and to try to find reasons for “unexplained” infertility. Factors being studied include blood-clotting factors, amino acids, and markers of egg aging.
Principal Investigator: Kurt Barnhart, MD, MSCE
Using MRI to Study Vaginal Architecture
This is a research study that is designed to study the shape and contour of vaginal anatomy using Magnetic Resonance Imaging (MRI). The goal of this project is to compare MRI images obtained from Chinese women to corresponding images of Caucasian women from previous studies. Participation in this trial lasts up to one month. Volunteers must be healthy women, aged 18 to 30, who have regular menstrual cycles and have had no children. They must also have been born of native Chinese parents and raised in China.
Principal Investigator: Kurt Barnhart, MD, MSCE
Feasibility Study of Intrauterine Administration of Radio-Opaque Gel in Women
A new form of non-surgical sterilization for women is currently being developed. This procedure uses a gel, which is injected into the uterus and fallopian tubes and causes the tubes to close. Before this procedure can be used, preliminary tests must be done. This study is using a placebo (non-active) gel to examine the best way to inject the gel into the uterus, and also to assess how well the gel spreads. Participants will undergo the gel injection, and will then be assessed by x-ray. Each person in the study will participate for approximately one month, though follow-up could be longer. Participants must be healthy women, aged 25 to 45, who are using an effective method of birth control, have at least one living child and do not desire to have more children.
Principal Investigator: Kurt Barnhart, MD, MSCE
NOMAC/E2 vs. DRSP/EE for Contraception
A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drospirenone (DRSP) and 30 μg ethinyl estradiol (EE). Healthy women between the ages of 18 and 50 will be recruited into this study to evaluate a new OCP containing NOMAC and estradiol. The period of participation for each subject is 13 cycles. Participants will be randomized to either this new product or to one with the same active ingredients as “Yasmin.” The study will compare these two pills with regards to contraceptive efficacy, cycle control, safety and acceptability (quality of life, libido, acne and menstrual symptoms). Principal Investigator: Kurt Barnhart, MD, MSCE
Stability and Epigenetic Structures in ART Children
This five year prospective study seeks to determine whether Assisted Reproductive Technology (ART) increases the possibility of deregulated expression of imprinted genes and/or destabilizes epigenetic chromosomal marking. It is hypothesized that in vitro manipulation procedures and/or intracytoplasmic sperm injection (ICSI) can destabilize the faithful propagation of epigenetic structures in the genomes of cells of the human embryo. With samples of cord blood, cord and placental tissue this study will look at and compare the regulation of such genes in 500 babies conceived with ART and 500 babies conceived without any fertility drugs and/or procedures.
Principal Investigator: Christos Coutifaris, MD, PhD
Ovarian Tissue Freezing Prior to Chemotherapy or Radiation Therapy
Chemotherapy and radiation therapy for cancer can compromise the ability to become pregnant. The primary objective of this study is to establish a technology that will enable long-term preservation of ovarian function, including the production of viable oocytes, by cryopreservation of ovarian tissue prior to chemotherapy and/or radiation. Another aim of the study is to develop in vitro techniques that will allow maturation of oocytes from the cryopreserved ovarian tissue. Before receiving chemotherapy or radiation therapy, subjects will have one of their ovaries, or small pieces of both ovaries, removed by surgery. The tissues will be frozen by a special method in an effort to prevent the eggs from being damaged. The majority (80%) of the tissue will be stored for potential use in case that the patient is unable to achieve pregnancy in the future, while the remainder (20%) will be used for studying how the eggs can be grown in the laboratory. Female patients, aged 18-42, in need of cancer treatment likely to adversely affect ovarian function, may be eligible to participate.
Principal Investigator: Clarisa Gracia, MD, MSCE
Treatment for Hypoactive Sexual Desire Disorder
This study aims to evaluate the safety and efficacy of Filbanserin in treating Hypoactive Sexual Desire Disorder (HSDD). Subjects will be randomized to either the study treatment or a placebo to use daily for 32 weeks. Participants must be pre-menopausal, on an effective form of birth control, and have been diagnosed with HSDD lasting at least 24 weeks.
Principal Investigator: Clarisa Gracia, MD, MSCE
A Pilot Randomized Controlled Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population
This trial will assess the feasibility of recruiting and retaining postpartum teens in a randomized controlled trial of advanced supply of Levonorgestrel Emergency Contraception (LNG EC) compared to routine care. Estimates will be obtained of the prevalence of the use of LNG EC, primary contraceptive method continuation, unprotected intercourse exposure, and pregnancy rates in postpartum teens given advanced supply of LNG EC and those who are delivered routine care. A focus group substudy will be used to develop and implement methods to improve retention of subjects. The study population will consist of women 19 years of age and younger, immediately postpartum, who are delivered of a live infant at the Hospital of the University of Pennsylvania.Principal Investigator: Courtney Schreiber, MD, MPH
A Pilot Study to Evaluate A Physician-Assisted Decision Tool to Improve Continued Contraceptive Use and Extend the Interval to the Next Pregnancy Compared with Routine Care
This cohort study will explore whether focused contraception counseling using a novel tool improves contraception adherence in the post-partum period. Subjects will be recruited from the population of adult women ≥ 32 weeks gestational age presenting for prenatal care at the Helen O. Dickens Center at the Hospital of the University of Pennsylvania. They will be randomly assigned to receive either contraceptive counseling using the decision tool or routine care. Subjects will complete a questionnaire surveying experiences and opinions on contraception and contraceptive counseling at a prenatal visit and by phone at three months postpartum. Principal Investigator: Courtney Schreiber, MD, MPH
Weight Loss Surgery and Male Fertility
This investigator-initiated, single-site, observational study aims to determine whether gastric bypass surgery and associated subsequent weight loss have any effect on male fertility, using semen analysis and reproductive hormones as markers. Participants will be recruited from the pre-operative pool of adult male bariatric surgery candidates, ages 18-65, at the University of Pennsylvania. Subjects will be asked to provide semen and blood samples for analyses pre-operatively and at post-operative visits for two years following surgery, and will receive cryopreservation and storage of pre-operative sperm samples at no cost for the length of their participation in the study. Principal Investigator: Carmen Williams, MD, PhD
HPV Pap Smear Reliability Study
This study aims to assess the reliability of 2 new pap smear tests for detecting HPV in two groups of women. Group one will include women age 18 and over with abnormal pap smears who will be given follow-up care, including colposcopy and possible biopsy Group two will include women age 30 and over with normal pap smears who will be assessed on an annual basis for 3 years. Principal Investigator: Michelle Vichnin, MD
Gynecology Oncology
Newly Diagnosed Ovarian Cancer
GOG212: A randomized phase III trial of maintenance chemotherapy comparing 12 monthly cycles of single agent paclitaxel or ct-2103 (ind# 70177), versus no treatment until documented relapse in women with advanced ovarian or primary peritonealcancer achieve a complete clinical response to primary platinum/ taxane chemotherapy. Principal Investigator: Dr. Maurie Markman
GOG218: A phase III trial of carboplatin and paclitaxel plus placebo versus carboplatin and paclitaxel plus concurrent bevacizumab (nsc #704865, ind#7921) followed by placebo, versus carboplatin and paclitaxel plus concurrent and extended bevacizumab. in women with newly diagnosed, previously untreated, stage III or I, epithelial ovarian or primary peritoneal cancer nci-supplied agent(s): bevacizumab/placebo (nsc #704865, ind#792).Principal Investigator: Dr. Robert Berger
Recurrent Ovarian Cancer
UPCC-11807: A phase I clinical trial of autologous debdritic cell vaccine loaded with autologous tumor cell lysate combined with bevacizumab and low dose cycclophosphamide for recurrent ovarian and primary peritotenal cancer. Prinicipal Investigators: Dr. George Coukos*
UPCC-01808: A phase I/II randomized trial of maintenance vaccination combined with oral metronomic cyclophosphasmide with or without adoptive transfer of vaccine primed CD3/CD28-costimulated autologous T-cells for recurrent ovarian or primary peritoneal cancer previously vaccinated with autologous tumor dentritic cell vaccine. Prinical Investigator: Dr. George Coukos*
*These two trials are conducted in sequence
UPCC-02809: A Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer with symptomatic ascites. This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy for ascites palliation of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer who have evidence of symptomatic ascites. Principal Investigator: Dr. George Coukos
Platinum Sensitive Ovarian Cancer
UPCC-06807: A Phase I, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination with Carboplatin and Docetaxel in Women with Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer. Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. Principal Investigator: Dr. Christina Chu
GOG9917: A dose-escalating phase i study with an expanded cohort to assess the feasibility of intraperitoneal carboplatin (nsc # 214270) and intravenous paclitaxel (nsc #673089)and intravenous paclitaxel, intraperitoneal carboplatin and nci supplied agent intravenous bevacizumab (nsc 704865; ind 7921) in patients with previously untreated epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. Principal Investigator: Dr. Mark A Morgan.
GOG0213: A phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with becvacizumab (nsc #704865, ind#7921) followed by bevacizumab (nsc 704865; ind 7921) followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritonerimary and fallopian tube cancer. mci-supplied agents: becvacizumab (nsc #704865, ind#7921), Principal Investigator: Dr. Robert Coleman
Platinum Resistant Ovarian Cancer
UPCC-04808: A Phase I, Dose Escalation Clinical Trial of Liposomal Pegylated Doxorubicin and Interleukin-18 Combination in Recurrent Advanced Stage Epithelial Ovarian Cancer. The purpose of this study is to identify a dose of SB-485232, which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. This study will use a standard treatment regimen of pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies to evaluate the efficacy of this combination. Principal Investigator: Dr. Christina Chu
UPCC-06507: A phase I, open label, dose escalation, multiple dose study of the safety, tolerability, and immune response of crs-207 in adult subjects with selected advanced solid tumors who have failed or who are not candidiates for standard treatment. Principal Investigator: Dr. Dan Sterman, Co-Principal Investigator: Dr. George Coukos
GOG0186F: A phase II evaluation of docetaxel (nsc#628503) plus trabectedin (yondelis, r279741, ind 101018) with growth factor support in the third-line treatment or recurrent or persistant ovarian, fallopian tube or primary peritoneal cancer. Principal Investigator: Dr. Bradley J Monk
Study of the Immunogenicity of Killed Influenza Vaccine in Patients with Advanced Ovarian and Primary Peritoneal Cancer in Remission
Influenza is a serious disease and affects people of all ages, with 36,000 deaths and over 200,000 hospitalizations per year in the United States.
Vaccination is currently recommended by the Centers for Disease Control for individuals with a weakened immune system, including people receiving cancer treatment. Over 1 million patients received chemotherapy last year. This represents a significant population of people with unique vulnerabilities to influenza. Not only are the patients themselves vulnerable, but they could compromise the non-immunocompromised population through increased spread of the virus. Therefore, it is important to understand their immune response. T cells are important in the containment of infection and in stimulating an immune response. Studies have found that in ovarian cancer patients, there
is a dysregulation of T cells. This may explain the historically poor vaccine
responses seen in patients with tumors. This study will examine this vaccine failure in patients with ovarian cancer. Patients will be given the influenza vaccine and blood will be drawn at different times to study the immunologic responses. Principal Investigator: Christina Chu, MD
Randomized Phase I/II Study of the Immunogenicity of Cyclophosphamide with Peptide Pulsed Mature Dendritic Cells for Patients with Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma
This study is s phase I/II trial of a matured autologous dendritic cell vaccine for consolidation of patients with advanced epithelial ovarian or primary peritoneal cancer. Though 70% of patients with advanced disease respond to initial chemotherapy, most eventually relapse and die of chemotherapy resistant disease. There is currently no standard recommended consolidation therapy that has been proven to improve survival. This trial with administer an autologous dendritic cell vaccine loaded with Her2/neu and telomerase peptides. All patients will receive 4 doses of vaccine via intradermal injection at 3 week intervals. Half of the patients will be randomized to receive a single low dose of cyclophosphamide to help assess the effect of regulatory T cells. Endpoints for analysis include immune response, safety, time to progression and survival. Principal Investigator: Christina Chu, MD
Acquisition of Human Gynecologic Specimens & Serum to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of CA
This is a trial that provides for the collection of these specimens for the purpose of banking them for use in future research. Participants need only give theirpermission for the collection and retention of tumor tissue being removed at the time of their surgery. Principal Investigator: Stephen C. Rubin, MD
A Phase II Evaluation of Irofulvan in the Treatment of Recurrent or Persistent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
This is a treatment trial for women with recurrent or persistent ovarian cancer or primary peritoneal cancer who have already been treated with and had a responseto a platinum-based chemotherapy regimen. They will be treated with Irofulvan, a cytotoxic agent, via a 30 minute IV infusion on Day 1 and Day 8 in 21 day cycles, until progression or unacceptable toxicity. Principal Investigator: Stephen C. Rubin, MD
A Phase II Evaluation of CCI-779 in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
This is a treatment trial for women with recurrent or persistent epithelial ovarian or primary peritoneal cancer who have previously been treated with a platinum-based chemotherapy regimine and have either had a progression of disease during this treatment or persistent disease following completion. They will be treated with temsirolimus (CCI-779), a non-cytotoxic agent, via weekly 30 minute IV infusions progression or unacceptable toxicity. Principal Investigator: Stephen C. Rubin, MD
A Randomized Study of Tamoxifen versus Thalidomide in Patients with Biochemical-Recurrence-Only in Epithelial Ovarian Cancer, Cancer of the Fallopian Tube,and Primary Peritoneal Carcinoma after First Line Chemotherapy
This is a treatment trial for women with epithelial ovarian cancer, cancer of the fallopian tubes or primary peritoneal cancer who have had a complete response to a first-line platinum/taxane-based and now have biochemical recurrence (no radiographic or clinical evidence of measurable disease, but elevated CA 125 that had been normalized). They will be randomized to receive either thalidomide, 200mg po daily with weekly dose escaltion to maximal dose of 400mg VS. tamoxifen 20 mg po BID until progression, unacceptable toxicity or 1 year, whichever comes first. Principal Investigator: Stephen C. Rubin, MD
A Randomized Phase III Trial of Maintenance Chemotherapy comparing 12 monthly Cycles of Single Agent Paclitaxel or Xyotax Versus No Treatment Until Documented relapse in women With Advanced Ovarian or primary peritoneal Cancer Who Achieve A complete Clinical Response to Primary Platinum/Taxane Chemotherapy
This is a treatment trial for women with primary peritoneal cancer or stage III or IV ovarian cancer who have no symptoms suggestive or persistant cancer, normal physical exam, normal CT scan of the abdomen/pelvis and serum CA-125 after receiving 5-8 cycles of platinum/Taxane therapy. They will be randomized to receive either Xyotax (10-20 min infusion) every 28 days X 12; paclitaxel (3 hour infusion) every 28 days X 12 or no further treatment until evidence of disease progression. Principal Investigator: Stephen C. Rubin, MD
A Phase III Trial of Carboplatin & Paclitaxel plus Placebo vs Carboplatin & Paclitaxel plus Concurrent Bevacizumab Followed by Placebo vs Carboplatin & Paclitaxel plus Concurrent & Extended Bevacizumab in Women with Newly Diagnosed Previously Untreated Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer
This is a randomized treatment trial for women with stage III/IV epithelial ovarian or primary peritoneal cancer that have been suboptimally debulked. All patients will be initially randomized to receive either taxol/carbo (6 cycles)+ Bevacizumab(beginning with cycle 2-5 cycles) (2/3) or taxo/carbo (6 cycles) + placebo (beginning with cycle 2-5 cycles) (1/3). They will receive drug via IV infusion on Day 1 every 21 days. Patients that received Bevacizumab in stage 1 will then be re-randomized to receive either placebo or Bevacizumab via a 30 minute IV infusion every 21 days for an additional 16 cycles. ½ of the patients get it again, ½ will get placebo. All of the patients that got placebo in stage 1 will again receive placebo. Principal Investigator: Stephen C. Rubin, MD
A Dose-Escalating Phase I Study with an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin and IV Paclitaxel in Previously Untreated Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
This is a treatment trial for women with previously untreated epithelial ovarian or primary peritoneal or fallopian tube cancer. Within 12 weeks of primary surgery for these diseases, treatment with intraperitoneal carbo at a starting dose of AUC 6 will be administered with IV paclitaxel once every 21 days (one cycle). Dose reductions for toxicity are allowed. There are no intra-patient dose escalations. Treatment continues until either excessive toxicity or disease progression for a maximum of 6 cycles. Principal Investigator: Stephen C. Rubin, MD
A Randomized Phase III Trial of Paclitaxel plus Cisplatin vs Vinorelbine plus Cisplatin vs Gemcitabine plus Cisplatin vs Toptecan plus Cisplatin in Stage IVB Recurrent or Persistent Carcinoma of the Cervix
This is a treatment trial for women with primary stageIVB or recurrent/persistent carcinoma of the cervix with measurable disease and no prior chemotherapy. These women will be randomized to 1 of 4 treatment regimens: #1 24H IV taxol infusion followed on day 2 with IV cisplatin repeated Q3 weeks for 6 cycles; #2IV vinorelbine and cisplatin on day 1 followed by IV vinorelbine on Day 8 repeated Q3 weeks for 6 cycles; #3 IV gemcitabine and cisplatin on Day 1followed by IV gemcitabine on Day 8 repeated Q3 weeks for 6 cycles; #4 topotecan and cisplatin on Day 1 followed by IV topotecan on Days 2 and 3 to be repeated Q3 weeks for 6 cycles. Principal Investigator: Stephen C. Rubin, MD
A Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF vs Carboplatin/Paclitaxel in Patients with Stage III& IV or Recurrent Endometrial Cancer
This is a treatment trial for women with Stage III, IV or recurrent endometrial cancer. Patients will be randomized to 1 of 2 treatment regimines. If they are randomized to regimen I (Doxorubicin and cisplatin day 1, paclitaxel day 2 and G-CSF SQ days 3-12), they will need to have an LVEF assessment and those with a result of <50% will automatically crossover to regimen II (taxol and carbo on Day1 Q 21 days for 7 cycles. Patients with a known LVEF of <50% within 6 months of study entry are ineligible. Principal Investigator: Stephen C. Rubin, MD
Maternal Fetal Medicine
Predicting Preterm Birth and Adverse Neonatal Outcomes with Novel Biomarkers: Identifying Those at Greatest Risk to Allow for Future Therapeutic Trials
This is a single-center cohort study enrolling women between 22 and 34 weeks gestational age who are at risk for preterm birth. The objective of the study is to determine whether or not certain novel biomarkers are predictive of preterm birth in an effort to provide enhanced medical care to patients at risk for preterm birth. We will compare outcomes of these pregnancies in women who subsequently deliver preterm to those who do not deliver preterm. A total of 1210 subjects will be enrolled.
Principal Investigator: Michal A. Elovitz, MD
Periodontal Infection and Prematurity Study (PIPS)
Periodontal disease has been linked to preterm birth in numerous epidemiological studies. The prevalence of periodontal disease is highest in underserved populations, with some estimates as high as 40-50%. PIPS is a multidisciplinary investigation of screening and treating periodontal disease with the hopes of reducing the rate of spontaneous preterm birth. The study is a randomized clinical trial that will include a total of 2,100 subjects, recruited from HUP, Pennsylvania Hospital and Albert Einstein Medical Center. Women with periodontal disease are randomized to either scaling and root planing or tooth polishing. The subjects are followed for the occurrence of the primary outcome- spontaneous preterm birth at less than 35 weeks gestation. The study will also evaluate, in a subset of those enrolled in the study, some of the potential mechanisms through which periodontal disease may exert its effect. This will include the evaluation of maternal cytokines, maternal matrix metalloproteinases, and genetic polymorphisms that may relate to the degree of inflammatory response. Principal Investigator: Samuel Parry, MD, Co-Principal Investigators: George A. Macones, MD and Marjorie Jeffcoat, DMD
Preeclampsia: Mechanisms and Consequences
It is a case-control study to evaluate preeclampsia. This study involves a large clinical and biological database (including maternal serum, maternal DNA and fetal DNA). On-going projects within this study involve the interaction of fetal growth restriction with preeclampsia, the association of metabolic syndrome with preeclampsia, short-term cardiovascular outcomes after preeclampsia, racial disparity in severity of disease and several others. Principal Investigator: Michal A. Elovitz, MD
Acquisition of Human Specimens for Use in the Diagnosis and Management of Preeclampsia and Other Related Conditions
The overall objective of this study is to collect serum and urine specimens that will be stored frozen and used in the research and development of tests for preeclampsia and other related conditions. Personnel employed by Abbott Laboratories, Chicago, IL or their designee and site personnel will conduct this research and development. Genetic testing will not be performed on the specimens. The University of Pennsylvania School of Medicine will enroll a minimum of approximately 900 patients (total). The enrollment phase of the study will be terminated at all sites once the overall targeted number of women have been enrolled. Principal Investigator: Samuel Parry, MD
Urogynecology
Randomized, double blind study to evaluate the efficacy, safety and tolerability of reboxetine succinate for urge urinary incontinence in women.
Women with urge urinary incontinence are eligible to participate. Women will be closely monitored for efficacy (improvement of urinary symptoms) and safety and tolerability of the drug. Principal Investigator: Lily A. Arya, MD
Randomized, double blind study to evaluate the efficacy, safety and tolerability of reboxetine succinate for stress urinary incontinence in women.
Women with stress urinary incontinence are eligible to participate. Women will be closely monitored for efficacy (improvement of urinary symptoms) and safety and tolerability of the drug. Principal Investigator: Lily A. Arya, MD
A Multiple Dose, Randomized, Double-Blind Multicenter Study of the EFFICACY and safety of pregabalin Compared to Placebo in the Treatment of Patients with Post-Surgical Pain from HYSTERECTOMY
Randomized double blind study to evaluate a new drug for pain control following hysterectomy. Women undergoing hysterectomy by a transverse incision will be givendrug or placebo to evaluate safety and efficacyfor postoperative pain. Principal Investigator: Lily A. Arya, MD
Women's Health
Short-term versus Long-term Treatment for Premenstrual Syndrome (PMS)
This is a randomized, double-blind clinical trial supported by the National Institutes of Health. All participants who meet criteria for PMS will be treated with sertraline. Withdrawal from the medication to a placebo is double-blinded. Participation is to 21 months. Principal Investigator: Ellen W. Freeman, PhD
Study of an Oral Contraceptive in a Continuous Daily Regimen for Premenstrual Dysphoric Disorder (PMDD)
This is a randomized, double-blind clinical trial supported by Wyeth. Eligible women who meet criteria for PMDD will be treated with an oral contraceptive or placebo. Participation is to 7 months. Prinicpal Investigator: Ellen W. Freeman, PhD
Study of a Non-Hormonal Medication for Treatment of Heavy Menstrual Bleeding
This is a randomized, double-blind clinical trial supported by Xanodyne Pharmaceuticals. Eligible women will be treated with the medication or a placebo. Participation is to 7 months. Principal Investigator: Ellen W. Freeman, PhD
Study Extension of a Non-Hormonal Medication for Treatment of Heavy Menstrual Bleeding
Supported by Xanodyne Pharmaceuticals. Participation in initial study is required. All participants will receive active medication to 9 months. Principal Investigator: Ellen W. Freeman, PhD
Escitalopram for Premenstrual Syndrome (PMS) in Teens
This is a randomized, double-blind clinical trial supported by Forest Pharmaceuticals. Eligible teens will receive escitalopram or a placebo. Participation is to 6 months. Principal Investigator: Ellen W. Freeman, PhD
