We currently manage more than 55 clinical trials and other studies funded by Bayer, Merck, National Institutes of Health, National Cancer Institute and National Institute of Child Health and Human Development, among others.
Our Clinical Trials Office (CTO) was established in 1997 and is led by Lisa Keder, MD. The CTO has participated in numerous large-scale, industry-sponsored, multicenter trials and has maintained subject continuation rates greater than 90% and data collection close to 100%.
Title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-102) for the Prevention of Pregnancy in Women
Purpose of the Study: To demonstrate the efficacy and safety of 28-day combination oral contraceptive regimen (21 days of desogestrel/ethinyl estradiol [DSG/EE] followed by seven days of EE) taken for one year in women desiring pregnancy prevention.
Description: This is an open-label, single-treatment study. After a screening period of approximately four weeks, women will take study drug/investigational product for one year. Participants will have routine clinic visits and follow-up phone calls during the study to assess compliance and adverse events. During the study, women will complete a daily electronic diary.
Eligibility Criteria: Sexually active women, age 18-40 years who are at risk for pregnancy and agree to routinely use study drug/investigational product as their only birth control method during the study. Exclusion criteria include any condition that contraindicates the use of oral contraceptives. Other exclusionary criteria are breastfeeding, pregnancy, smoker ≥ 35 years and history of receiving Depo-Provera within six months.
Study Status: Closed to enrollment.
Principal Investigator: Lisa Keder, MD, MPH
Funding: Teva Women’s Health Research
Title: A Phase 3, Randomized, Multicenter, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System (20 mcg/day) and Mirena® for Long-Term, Reversible Contraception up to Five Years
Purpose of the Study: To assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in women of child-bearing ability who request long-term, reversible contraception.
Description: The study is a randomized, multicenter, open-label evaluation of the efficacy of a levonorgestrel-releasing intrauterine system (IUS). A marketed IUS (Mirena) is being used as a comparator. The Mirena arm of the study is closed to randomization and the experimental IUS arm is being actively recruited. Women will be evaluated at follow-up clinic visits for up to 60 months. There will also be follow-up telephone calls/emails. Women will complete a daily diary.
Eligibility Criteria: Women who are healthy and between the years of 16-45 will be included. Women must be in a mutually monogamous relationship for at least six months and be regularly sexually active. They must be willing to rely on the study IUS as the primary method of contraception during the study. Women will be excluded if they are breastfeeding, currently pregnant or have used Depo-Provera within the past nine months.
Study Status: Closed to enrollment.
Principal Investigator: Lisa Keder, MD, MPH
Funding: Medicines360, Inc.
Title: FOCUS: International Active Surveillance Study – Folate in Oral Contraceptives Utilization Study
Purpose of the Study: Researchers from Europe and the United States are studying if there are differences in the chance of health-related risks or benefits associated with oral contraceptives among women. The primary objective of this study is to assess the risks of short- and long-term use of oral contraceptives plus folate, in comparison to established oral contraceptives.
Description: Women will be recruited from physician offices and the OSU Wexner Medical Center Ob/Gyn Clinic to complete a short questionnaire about their medical history. Women complete the questionnaire and return it to the sponsor in a self-addressed stamped envelope. By mail, the sponsor will send a short follow-up survey every 6 – 12 months for at least four years to monitor any changes in health and well-being.
Eligibility Criteria: Women age 12 and older who are ordered a combined oral contraceptive are eligible. The women may be first-time users of oral contraceptives or they may be switching from one pill to another. Also included are those women restarting an oral contraceptive prescription.
Study Status: Open to enrollment.
Principal Investigator: Lisa Keder, MD, MPH
Funding: Juergen Dinger, MD, MPH (Berlin, Germany)
Title: Telephone Counseling Intervention to Increase Highly Effective Contraceptive Method Use at Six Months Postpartum
Purpose of the Study: To increase long-term highly effective postpartum contraceptive use and ultimately decrease unplanned pregnancy. To achieve this goal, the impact of a telephone call one month postpartum to discuss contraception will be evaluated.
Description: Women were recruited from the postpartum service at The Ohio State University Wexner Medical Center. Women were randomized to the control group or the intervention group. All received standard postpartum contraceptive education and materials. Women randomized to the intervention group received a telephone call at one month postpartum. During the call, study personnel readdressed contraceptive use, answered any questions and helped facilitate the initiation of a contraceptive method if it had not already started. All participants (control and intervention groups) were contacted by phone at six months postpartum and asked about current contraceptive use.
Eligibility Criteria: Women who were postpartum from a vaginal delivery or cesarean delivery at greater than 34 weeks’ gestation and had some prenatal care were included. Women were excluded if they desired permanent sterilization or had no working telephone.
Study Status: Closed to enrollment – data being analyzed.
Principal Investigator: Michelle Isley, MD, MPH
Funding: ACOG/Bayer Healthcare Pharmaceutical Research Award
Title: In Women, Abnormal Uterine Bleeding (AUB) Complicates Use of Long-Term Progestin-Only Contraceptive (LTPOC) Agents
Purpose of the Study: To identify and assess mechanisms in the endometrium that mediate AUB.
Description: LTPOCs are safe, effective and inexpensive and therefore ideal for use by women in developing countries. They are discontinued primarily because of AUB, which does not compromise health, but is a source of severe annoyance and in some societies of religious taboo. Unlike menstrual bleeding, AUB stems from distended, fragile endometrial microvessels. Laser Doppler Fluxmitry measurements indicate that LTPOC administration to women markedly reduces utero-placental blood flow eliciting local hypoxia and generation of microvessel damaging reactive oxygen species. The resulting increase in microvascular permeability increases contact of factor VII from the circulation to Tissue Factor (TF), expressed by surrounding highly decidualized endometrial stromal cells. Excess generation of thrombin by TF acts as an autocrine/paracrine stimulator of decidualized endometrial stromal cells to promote AUB via increased expression of: 1) vascular endothelial growth factor, which further increases microvascular permeability; and 2) Matrix metalloproteinases 1 and 3, which degrade the extracellular matrix microvascular support structure.
Eligibility Criteria: Non-applicable.
Study Status: Closed.
Funding: NIH
Title: Long-Term Follow-Up of Children Diagnosed With Urologic or Bladder Disorders Before Birth
Purpose: To learn more about the outcomes of children diagnosed before birth with obstructive problems in the urologic system as related to any fetal treatment that is performed.
Description: Mothers who choose to participate in this study agree to provide the researchers with information about their surviving child until four years of age. Information about all health care needed by the affected child is gathered by phone or from medical records. No extra appointments are needed for this observational study.
Eligibility Criteria: Found to have an obstruction in the renal system during a pregnancy that is being care for at OSU Wexner Medical Center and delivery of a surviving child who goes home.
Study Status: Open and enrolling.
Principal Investigator: Richard O’Shaughnessy, MD
Contact: Karen Rossi, RN, 614-293-8083
Title: Antibodies in Pregnancy
Purpose: To learn more about the effect of antibodies on fetuses and newborns so the best treatments can be provided.
Description: All information about the routine clinical care provided during pregnancy and after birth to manage alloimmunization (antibodies) is collected. This study includes information on all pregnancies managed at OSU Wexner Medical Center since 1959, making it the largest source of information in the United States.
Eligibility Criteria: Patients who have a blood sample analyzed at OSU Wexner Medical Center Prenatal Reference Laboratory are included.
Study Status: Open and enrolling.
Principal Investigator: Richard O’Shaughnessy, MD
Contact: Karen Rossi, RN, 614-293-8083
Title: Natural History Registry for Pregnancies Complicated by Prenatally Diagnosed Lower Urinary Tract Obstruction With Normal Amniotic Fluid Volume
Purpose: To observe the natural course and pediatric outcomes of pregnancies with this problem to determine if fetal treatment should be used in this group in the future. This is a multisite study coordinated by Dr. Anthony Johnson through the North American Fetal Treatment Network.
Description: Enrolled patients agree to allow the information about the ultrasound findings during their pregnancy and the health care required by their child until two years of age to be collected by researchers during routine office visits and phone calls after delivery.
Eligibility Criteria: Diagnosis with this problem before 24 weeks’ gestation at OSU Wexner Medical Center.
Principal Investigator: Richard O’Shaughnessy, MD
Study Status: Open and enrolling.
Contact: Karen Rossi, RN, 614-293-8083
Title: Randomized Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Purpose: Evaluate the effect of different treatments on babies with alloimmune thrombocytopenia. This is a multisite trial coordinated by Dr. James Bussell at New York Presbyterian Hospital.
Description: Women are categorized by the severity of their disease based on their history and then randomized to a treatment plan. All information about the care of the pregnancy and the newborn is then collected by the researchers.
Eligibility Criteria: Diagnosed with alloimmune thrombocytopenia and receiving treatments at OSU Wexner Medical Center.
Study Status: Open and enrolling.
Principal Investigator: Richard O’Shaughnessy, MD
Contact: Karen Rossi, RN, 614-293-8083
Title: Development of a Noninvasive Fetal Aneuploidy Test
Purpose: This industry-sponsored study aims to obtain FDA approval for a blood test that screens for trisomy 21.
Description: One blood sample is required before the amnio or CVS is done.
Eligibility Criteria: Pregnant patients less than 24 weeks who have already chosen to have an amniocentesis or chorionic villus sampling.
Study Status: Open and enrolling.
Principal Investigator: Britton Rink, MD
Contact: Karen Rossi, RN, 614-293-8083
Title: Effects of Prenatal Diagnosis on Delivery
Purpose: To study whether babies diagnosed with a fetal defect before birth are electively delivered before full term.
Description: The age of the baby at birth and the reasons for the delivery are obtained.
Eligibility Criteria: Pregnancies found to have a fetal problem before delivery that are delivered at OSU Wexner Medical Center.
Study Status: Open and enrolling. Planning to expand the study to more sites in late 2012.
Principal Investigator: Britton Rink, MD
Contact: Karen Rossi, RN, 614-293-8083
Title: Outcomes of Twin-Twin transfusion
Purpose: To study the effects of treatment provided during pregnancy for twin-twin transfusion.
Description: Information about the growth and development and healthcare needs of surviving infants is gathered from phone calls and medical records until two years of age.
Eligibility Criteria: Diagnosis and treatment at OSU Wexner Medical Center with twin-twin transfusion.
Study Status: Open and enrolling.
Principal Investigator: Richard O’Shaughnessy, MD
Contact: Karen Rossi, RN, 614-293-8083
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Purpose: To evaluate whether antenatal corticosteroids can decrease the rate of respiratory complications in the baby, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late-preterm infant.
Description: Women who consent for participation will receive two doses of betamethasone/placebo 24 hours apart. The study drug medication will be administered as an injection. Those with a planned delivery will receive study drug two to seven days prior to delivery.
Eligibility Criteria: Pregnant women ages 18-48 years with a singleton pregnancy and high probability of delivery in the late-preterm period (between 34 0/7 and 36 5/7 weeks).
Study Status: Open.
Principal Investigator: Mona Prasad, DO, MPH
Contact Information: Francee Johnson, RN, BSN, 614-293-5632
Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Title: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Purpose: To determine whether monthly maternal administration of CMV hyperimmune globulin during the entire pregnancy lowers the rate of congenital CMV infection.
Description: Cytomegalovirus is the most common congenital infection. Women presenting for prenatal care before 23 weeks’ gestation are eligible for CMV screening. Women who consent for screening will have a simple blood test performed at one of their routine prenatal visits. Women whose CMV screening identifies CMV infection during the current pregnancy will be asked to participate in the randomized trial. In the randomized trial, women will receive one of two monthly treatments until the end of pregnancy: IV CMV hyperimmune globulin or an identical-appearing placebo that contains no medication.
Eligibility Criteria: To be screened for the randomized trial, women must be between the ages of 18-48 and be pregnant with one baby. The screening blood test must be performed by 23 weeks in pregnancy. Women whose CMV screening testing identifies CMV infection during the current pregnancy will be asked to participate in the randomized trial.
Study Status: Opening soon.
Principal Investigator: Britton Rink, MD, MS
Contact Information: Francee Johnson, RN, BSN, 614-293-5632
Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Title: nuMoM2B- Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be
Purpose: To collect information to find ways to identify possible pregnancy complications in women who have not had a previous pregnancy beyond 20 weeks.
Description: Women are enrolled early in pregnancy and undergo research assessments four times during the pregnancy. Conditions to be focused on are high blood pressure, babies who are born much too early and very small babies. Data are collected through interviews, self-completed data forms, ultrasound and biological specimens. Information is also collected from medical records during pregnancy and at the time of delivery.
Eligibility Criteria: Women must be at least 16 years of age and pregnant for the first time (may have up to three previous miscarriages, none beyond 20 weeks). Enrollment occurs between six weeks to 14 weeks into the pregnancy and women must intend to deliver at OSUWMC.
Study Status: Open.
Principal Investigator: Jay Iams, MD
Contact: Cheryl Latimer, RN, MS, CCRC, 614-293-3782
Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Title: A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
Purpose: To test a new instrument, called a fetal STAN monitor, which may be used during labor to monitor the electrical activity of the baby’s heart. The goal for this study is to see if this monitor will have an impact on newborn health.
Description: The fetal STAN monitor has been approved by the FDA and is designed to help the doctor determine how well the baby is doing during labor. Currently doctors use the fetal heart rate and mother’s contraction pattern to determine how the baby is doing during labor. The fetal STAN monitor will additionally collect information on the electrical activity of the baby’s heart, giving physicians extra information to determine baby’s well-being. The monitor remains in place until delivery. Immediately after delivery, a small sample of blood will be taken from the umbilical cord to determine the level of oxygen in the baby’s blood. This blood is taken from a piece of umbilical cord cut between the baby and the placenta, so the baby will not feel discomfort. Information will be collected about how well mom and baby did during the hospital stay, and no follow-up is required after discharge.
Eligibility Criteria: To participate, women must be between ages 18-45, greater than 36 weeks pregnant and planning to have a vaginal delivery. They must also be pregnant with only one baby and have no history of uterine surgery.
Status: Open.
Principal Investigator: Katherine Strafford, MD
Contact Information: Francee Johnson, RN, BSN, 614-293-5632
Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Title: Assessing Reproductive Health Care for Women
Purpose: To understand the facilitators and barriers to women in obtaining reproductive health care, with a specific emphasis on contraception. The hope is to identify attitudes, logistics, financial concerns, educational awareness, medical concerns and healthcare availability in relation to contraception use.
Description: We are enrolling 500 women of reproductive age who are considered high risk for premature deliveries and rapid repeat pregnancies. Initial interaction involves a brief assessment of birth history, a reproductive healthcare questionnaire and birth control education followed by assistance with a birth control plan. Participants will then be periodically contacted (one to five times) over the next two years to assess attitudes and challenges and offer assistance related to available birth control options. At the end of the two-year period, county and state health department records will be searched (per consent) to identify enrolled women who have had a preterm birth or rapid repeat pregnancy during the two-year period. This data will then be compared to the rates of rapid repeat pregnancies and preterm births in the county, state and nation. The plan is to use the results from this study to lead to more rigorous research designs on contraception use and adherence in the future.
Eligibility Criteria: Women who are at least 18 years old, have an increased risk of a preterm birth, have a history of rapid repeat pregnancy and/ or are considered low income (no insurance or public assistance). Preference will be given to mothers who reside in Franklin County, Ohio.
Study Status: Open.
Funding: NCH
Title: The Stress and Health in Pregnancy and Postpartum (SHIPP) Study
Purpose: This study will examine associations of life stress with immune function, hormone levels and other markers of health including levels of certain fats (e.g., omega-3 fatty acids) in the blood of pregnant women. We are interested in whether these markers predict risk of preterm delivery and postpartum depression. We will also examine whether these markers differ based on race among African-American and Caucasian women across the course of pregnancy.
Description: This study will include 80 pregnant women (40 African-American and 40 Caucasian) who will begin the study during their first trimester of pregnancy and continue through 8-10 weeks postpartum. Participants will complete four total study visits to the OSU Wexner Medical Center. Visits will occur during the 1st, 2nd and 3rd trimester of pregnancy and at 8-10 weeks postpartum. At each study visit, participants complete questionnaires assessing their health, health behaviors, life stress and mood. Also at each study visit, a blood sample will be taken. Women may have the option of having study visits completed at their homes if this is more convenient for them. Participants will receive $230 if all study visits are completed.
Eligibility Criteria: Healthy pregnant women who are less than 15 weeks pregnant and between the ages of 18 and 35 are eligible to participate. Women may be smokers or nonsmokers. Women carrying twins or taking anticoagulants, cardiac medication, anti-inflammatories or steroids will be excluded.
Study Status: Open and currently enrolling.
Principal Investigator: Lisa Christian, PhD
Funding: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Title: Systems Biology Approaches to Study Preterm Birth
Purpose: To use systems biology approaches to create models for preterm birth.
Description: This research proposal will utilize an interdisciplinary team of clinicians, basic scientists, bioinformatics specialists and mathematicians to tackle one of the most vexing problems facing the field of obstetrics – preterm birth. We will do this by using a well-defined cell culture model of human decidua (endometrium of pregnancy) to profile the expression of both mRNAs that encode proteins and non-coding RNAs (microRNAs) that ‘fine-tune’ the expression of the mRNAs, following that with inflammatory substances and/or hormones that counteract such stimuli. These data will be used to perform computational modeling so that important insights into the regulatory control of induced RNA species can be achieved; these models can then be used to better predict those who will experience a preterm delivery, as well as shed light on new drug targets that may be used to treat preterm labor.
Eligibility Criteria: Female volunteers ages 18-44 years who are pregnant, at 37+ weeks of gestation, and are scheduled for cesarean delivery.
Study Status: Opening soon.
Funding: Internal
Title: Role of Ferlin Proteins in Trophoblast Function
Purpose: To identify the function(s) of ferlin proteins (dysferlin and myoferlin in particular) in trophoblast cell migration and invasion.
Description: We will utilize in vitro cell culture-based experiments to elucidate the role(s) of ferlin proteins in the migratory and invasive capacities of placentally derived cells. Our group has previously published on the presence of ferlin proteins in placental cells and the potential implication of these proteins in pre-eclampsia. The data from this project will be used to further the understanding of the function of ferlin proteins in the context of placental physiology and pathophysiology.
Eligibility Criteria: Not applicable, as this is a laboratory research study and does not involve recruitment of patients.
Study Status: Open.
Funding: Internal
Title: Lipid Bodies and Prostaglandin Production in Labor
Purpose: To define the role of lipid storage droplets in arachidonate metabolism and eicosanoid synthesis within intrauterine tissues during human labor.
Description: This research focuses on defining the role of lipid bodies (LBs) in arachidonic acid (AA) storage, mobilization and metabolism within cells of the amnion epithelium. The accumulation of numerous LBs with advancing gestation is a striking morphological feature of amniotic cells, although the role of these structures has not been clearly defined. The specific aims include: 1) determining the influence of labor on LB accumulation; 2) establishing the degree to which LBs associate with enzymes necessary for AA mobilization and metabolism; 3) determining the effects of LB perturbation on PG production; and 4) determining the effects of inhibited AA metabolism on LB formation.
Eligibility Criteria: Not applicable; this study is only open for data analysis and is no longer recruiting patients.
Study Status: Not applicable.
Funding: NIH
Title: Plasma Membrane Repair Mechanisms in Placental Trophoblasts
Purpose: To define the roles of dysferlin and myoferlin in trophoblast plasma membrane repair.
Description: The human placenta is a vital organ for the fetus during pregnant, and normal placental function requires that its cells undergo a continuous process of fusion, shedding and repair. We have identified two proteins, dysferlin and myoferlin, that may be essential for these fusion, shedding and repair processes. By studying how these proteins contribute to placental function, we will gain further understanding of placental diseases that may affect the well being of the fetus and pregnant women.
Eligibility Criteria: Female volunteers ages 18-44 years who are pregnant, at 37+ weeks of gestation, and are scheduled for cesarean delivery. This study only requires the collection of the placenta after delivery.
Study Status: Open.
Funding: NIH
Title: Decidual Cell Expression of Natural Killer Cell Recruiting Chemokines in Normal Pregnancy and Pre-eclampsia
Purpose: To study the chemokine expression in decidual natural killer (dNK) cells.
Description: First trimester human endometrium (decidua) comprises primarily decidual cells (50%) and an immune cell population (40%) dominated by CD56brightCD16- decidual natural killer (dNK) cells (70%) and macrophages (20%). Incubation of first trimester decidual cells with NK cell-derived interferon gamma (IFNγ) plus macrophage-derived tumor necrosis factor-alpha (TNF-a) synergistically enhance mRNA and protein expression of chemokines that recruit CXCR3-expressing NK cells, IP-10 and ITAC. This synergy requires IFNγ receptor (IFNγR1 and IFNγR2) mediation. Immunostaining of first trimester decidua localized high expression of IP-10, ITAC, IFNγR1 and R2 to vimentin-positive decidual cells. Flow cytometry identified high CXCR3 levels in dNK cells and the minority circulating CD56brightCD16- NK cells and intermediate levels in the majority CD56dimCD16+ NK cells. Incubation with IP-10 or ITAC produced concentration-dependent enhanced CXCR3 levels and migration of both circulating NK cell subsets. However, CXCR3 expression and NK cell migration were inhibited at high IP-10 and ITAC levels. dNK cells express pregnancy-promoting genes absent from either peripheral subset, suggesting that differentiation follows recruitment. Compared with gestational age-matched controls, in pre-eclampsia, a leading cause of maternal-fetal morbidity and mortality: 1) immunohistochemical staining of decidua found significantly lower dNK cell numbers and higher IP-10 in decidual cells; and 2) IP-10 levels are significantly higher in first trimester plasma from patients eventually developing pre-eclampsia. Decidual cell-mediated crosstalk between dNK cell- and macrophage-derived paracrine factors enhances IP-10 and ITAC expression to recruit additional circulating NK cells to the decidua; excess IP-10 leads to lower dNK cell numbers in pre-eclampsia.
Eligibility Criteria: Not applicable.
Study Status: Closed.
Funding: NIH
Title: Functional Progesterone Withdrawal in Decidua Mediates Abruption-Associated Preterm Delivery
Purpose: To examine levels of functional progesterone in decidual cells, both in situ and in vitro, in relation to preterm delivery.
Description: In most placental mammals, high endogenous progesterone levels maintain myometrial quiescence and declining plasma progesterone levels initiate labor. However, during human labor, placental progesterone production and plasma progesterone levels remain elevated. Moreover, human labor is induced by administration of a progesterone receptor (PR) antagonist, suggesting initiation by “functional P4 withdrawal” mediated by lower PR levels. Placental abruption (decidual hemorrhage), a leading cause of preterm delivery (PTD), is accompanied by excess thrombin derived from decidual cell expressed tissue factor. Immunostaining of placentas from abruption-associated PTD versus gestational-age matched controls revealed that among the cells at the maternal fetal interface, PR levels are significantly and exclusively lower in decidual cell nuclei in the abruption specimens. Lower PR levels are accompanied by significantly higher levels of the cell, signaling mediator phospho-ERK1/2 in decidual cells of abruption versus control decidua, whereas total ERK 1/2 is unchanged. Complementing these in situ observations, immunoblotting demonstrated that incubation of cultured third trimester human decidual cells with thrombin or medproxyprogesterone acetate (MPA) reduced and that MPA + thrombin further reduced PR expression. Thrombin also reduced PR binding to DNA and 3H-progesterone binding to PR while enhancing phospho-ERK1/2, but not total ERK1/2. Taken together, in situ and in vitro observations suggest that functional P4 withdrawal reflecting reduced PR expression in decidual cells mediates abruption-associated PTD.
Eligibility Criteria: Not applicable.
Study Status: Closed.
Funding: NIH
Title: A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL™, Dose-Ranging, Tolerability, Immunogenicity and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26-Year-Old Women
Purpose: To evaluate the best dose among those studied, of a 9-valent HPV vaccine, and then to study this dose for additional tolerability and immunogenicity and for efficacy.
Description: In Part A of this study, healthy 16- to 26-year-old women were randomized in equal numbers to one of three experimental 9-valent HPV vaccine formulations or the comparator GARDASIL™. The experimental vaccine was a three-dose regimen. The best 9-valent experimental HPV vaccine dose was selected for Part B of this study. During Part B, approximately 13,000 additional healthy 16- to 26-year-old women were randomized in equal numbers to the selected 9-valent HPV experimental vaccine chosen from Part A or the comparator GARDASIL™.
Eligibility Criteria: Women were included in this study if they were 16 – 26 years old and in good physical health. The women had a history of normal Pap test results or no history of Pap testing. Women were excluded if they had a history of HPV or ever received a marketed HPV vaccine in the past.
Study Status: Closed to enrollment – in follow-up.
Principal Investigator: Deborah Bartholomew, MD
Funding: Merck & Company, Inc.
Title: Role of Myoferlin in Biology of Women’s Cancers
Purpose: To identify the function of myoferlin in the biology of women’s cancers (breast, ovarian, sarcoma, etc.).
Description: We will utilize in vitro cell culture-based and in vivo mice-based experiments to elucidate the role(s) of myoferlin in breast/ovarian/etc. cell biology, such as adhesion, migration, invasion and metastasis. Myoferlin is a member of a family of human proteins previously primarily studied in the context of muscle development and myopathies. Our lab is the first group to investigate its role in cancer. The data from this project will be used to further the understanding of breast cancer and the potential role of myoferlin as a therapeutic target.
Eligibility Criteria: Not applicable, as this is a laboratory research study and does not involve recruitment of patients.
Study Status: Not applicable.
Funding: Internal and NSF Chemical, Bioengineering, Environmental, and Transport Systems (CBET) #1134201
Note: More Gynecologic Oncology clinical trials and studies can be found in the OSU Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute clinical trials database. Go to the
cancer clinical trials database and click on “Search by Disease Type” and choose “Gynecologic.”
