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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 members are 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 Infertility has been a member 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) and in the phase I and II clinical trials in ovarian cancer offered through the Center for Early Detection and Cure of Ovarian Cancer.

Reproductive Health / Infertility

Optimal treatment for women with a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of women at risk for an ectopic pregnancy: Active Treatment versus Expectant Management (No Treatment)  The “ACT or NOT TRIAL”

Reproductive Medicine Network

This is a multi-site randomized comparative efficacy trial of strategies to manage women identified to have a persisting pregnancy of unknown location (PPUL) (a nonviable gestation).  Randomization will be into active versus expectant management.  Additionally, women randomized to active management will be equally randomized between two active management strategies Active management   A) Determine the location of the pregnancy by a uterine evacuation, followed by a pathologic evaluation.  If no evidence of a uterine pregnancy is determined (i.e. non-visualized ectopic pregnancy), begin methotrexate dosage (50 mg/m2 given as an intramuscular injection) B) Empiric methotrexate treatment without determination of the location of the gestation.  Target enrollment at Penn is 50 women. Principal Investigator: Dr. Kurt Barnhart

A phase IIb randomized, double blind, comparative study to assess the efficacy, safety, tolerability and inhibition of ovulation of two continuous regimens of oral daily 5 mg or 10 mg of ulipristal acetate (UPA), versus a dose of 5.0mg UPA for 24/4 days.

Contraceptive Clinical Trials Network

This is a research study testing three different dose levels of an investigational birth control pill. The active ingredient in the pill is ulipristal acetate (UPA), an estrogen-free hormonal contraceptive. Participants make visits to our research center twice a week for 6.5 months to have an ultrasound and give a blood sample.  The primary objective is to compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg. Secondarily the tolerability and effects of the three different doses will be compared for bleeding, follicle growth, endometrial safety and subject satisfaction. Principal Investigator: Dr. Kurt Barnhart

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: Dr. Kurt Barnhart

Improving Psychological Health and Cardiovascular Disease Risk in Women with PCOS (MANI-PCOS)

The purpose of this clinical randomized trial is to help determine the best treatment plan for women with Polycystic Ovary Syndrome (PCOS) who are overweight or obese and experiencing symptoms of depression.  We want to look at how nutrition/dietary counseling and behavioral therapy may improve mood symptoms, response to stress, and risk factors for heart disease measured in blood tests.  Study participants will be asked to meet once weekly with a Registered Dietician for 16 weeks and with a Clinical Psychologist for 8 weeks.  Women with a diagnosis of PCOS who are overweight/obese and screen positive for symptoms of depression at the Penn PCOS Center may be eligible to participate.  Women who decide to participate in the study will receive one of two treatments:  1) Nutrition counseling plus Cognitive Behavioral Therapy, a specific type of therapy that addresses depression and anxiety,  2) Nutrition counseling alone.  We want to see if combining treatments has a different effect on mood symptoms, stress, and cardio-metabolic risk factors than nutrition counseling alone.  Principal Investigator: Dr. Anuja Dokras

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:  Dr. Anuja Dokras-Jagasia

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain

The Violet Petal Study is evaluating the safety and effectiveness of an investigational medication for moderate to severe endometriosis pelvic pain.  If you’re a woman age 18 to 49, and have been surgically diagnosed with endometriosis within the last seven years, you’re invited to see if you may qualify for the Violet Petal Study. The purpose of the research study is to evaluate the safety and effectiveness of an investigational medication for the management of moderate to severe endometriosis-associated pain and other endometriosis-related symptoms.  Compensation given for time and travel expenses.  Principal Investigator: Dr. Suneeta Senapati

Non-Invasive Imaging of Embryo Development

This study is designed to find a correlation between cleavage times in embryo development and live birth successes. This will be done using a miniature camera inside the incubation chambers that creates a time lapsed movie of the growing embryo after implantation. The study hopes to create a clinical standard in the future for choosing the best, most viable, embryos via cleavage times in addition to qualitative observations. Principal Investigator: Dr. Christos Coutifaris

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: Dr. Christos Coutifaris

  • For more information about our clinical trials in reproductive health and infertility, please call 215-662-7727 or send an email to reproresearch@obgyn.upenn.edu

Oncofertility

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. Ovarian tissue cryopreservation for adolescent girls ages 13-17 is available through a similar research protocol at the Children’s Hospital of Philadelphia under principal investigator Dr. Jill Ginsberg. Principal Investigator: Dr. Clarisa Gracia

Follicular and Luteal Dysfunction in Cancer Survivors (Daily Hormone Study)

 If you are between the ages of 20-35 or 43-50 with regular menstrual cycles and not using hormonal medications, we need you! Both women with a history of chemotherapy and women who have never had chemo are eligible. Give us a call if you think you might be interested. We would be happy to screen you for eligibility and answer your questions.  This is a 1-2 visit study. At your visit, we will do a brief interview, take your height and weight, do a urine pregnancy test and send you home with 2 boxes of 5 ml tubes for daily urine collection and freezing. You will only collect 5mls (about a teaspoon) a day. That’s it! At the end of two menstrual cycles, we will arrange for pickup of the frozen kits or you may deliver them to our office. You will be compensated for the study visit and each completed collection cycle. Principal Investigator: Dr. Clarisa Gracia

Assessing Fertility Potential in Female Cancer Survivors (For Non-Cancer Patients) Healthy women ages 11-35 are invited to participate in a 5-year study comparing changes in ovarian function over time to the same measures in cancer survivors. Eligible women will be asked to complete a yearly questionnaire, brief physical examination, pelvic ultrasound, a blood test andto keep a menstrualdiary. Participants must have regular menstrual cycles (every 21-35 days), a uterus and both ovaries, body mass index (BMI) less than or equal to 30, and no medical condition associated with early ovarian failure. Participants must not have been pregnant or breastfeeding in the 3 months prior to participation, and must not be using or have used hormonal medication including contraceptives in the 3 months prior to study participation. Compensation is available.  Principal Investigator: Dr. Clarisa Gracia

Assessing Fertility Potential in Female Cancer Survivors (For Cancer Survivors)
Cancer survivors 15 to 35 years of age with a history of treatment with chemotherapy or radiation are eligible to participate in this study. Eligible women will be asked to come to the Reproductive Research Unit at Penn Fertility Care to complete a questionnaire, a brief physical examination, an ultrasound and a blood test yearly to assess changing ovarian function over time after cancer therapy. Participants will also keep a menstrual diary between annual visits. In addition, participants in this study will have the option of undergoing an additional, more sensitive test to assess their ovarian function. This test is called the clomiphene challenge test and involves taking clomiphene citrate for five days and having a repeat blood draw on the 10th day of the menstrual cycle. Principal Investigator: Dr. Clarisa Gracia

Ovarian Reserve After Cancer: Longitudinal Effects (ORACLE) (For Non-Cancer Patients)
Healthy women ages 11-35 are invited to participate in a 2-year study comparing changes in ovarian function over time to women undergoing treatment for cancer. Participants must have regular menstrual cycles (every 21-35 days), a uterus andat least oneovary, no medical condition associated with infertility, no treatment with chemotherapy or radiation therapy and must not have been treated with chemotherapy or radiation therapy and not have been pregnant or breastfeeding in the 3 months prior to participation. Compensation is available.  Principal Investigator: Dr. Clarisa Gracia

Ovarian Reserve After Cancer: Longitudinal Effects (ORACLE) (For Cancer Patients)
Patients about to begin treatment with chemotherapy or radiation therapy, who are between the ages of 11 to 35 years, may participate in a study measuring ovarian function over time. Eligible women will be asked to complete a questionnaire, a brief physical examination, an ultrasound and a blood test before, during and after cancer treatment. Visits will occur every three months for a total of seven visits over 18 months. Every attempt will be made to coordinate research visits with clinical appointments. Principal Investigator: Dr. Clarisa Gracia

Assessment of Fertility and Factors Influencing Reproduction and Menopause in BRCA Mutation Carriers.  AFFIRM

Healthy women from ages 18-45 without a significant family history of breast cancer, ovarian cancer, and/or a BRCA mutation, are invited to participate in a study. Your information will be compared to women with increased genetic risk of cancer.  The goal of this study is to help women with increased genetic risk of cancer make decisions about when to start their families. This study includes a 30-minute online survey and a hormone measurement (eligible women will collect a few drops of blood on a special card by finger-prick on days 2-4 of their menstrual cycle). Eligible women will receive the blood spot kit by mail, and send the kit back within 24 hours of blood spot collection. Principal Investigator: Dr. Lauren Johnson

Gynecology Oncology

UPCC:  16813:  A Phase 2, Open-Label Study Of Rucaparib In Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer.

The experimental drug being investigated in this study is called rucaparib.  Rucaparib is being developed by Clovis Oncology, Inc., a biopharmaceutical company based in the US and the United Kingdom.  Rucaparib belongs to class of anti-cancer agents known as PARP inhibitors.  PARP is a protein inside cells in the body that helps repair damage to DNA, which is the genetic material that carries the instructions for your body’s growth and development.  Cancer can result from changes in a person’s genetic material (sometimes called DNA mutations) and some of these changes can cause cancer cells to grow out of control.  Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing.  If you complete the screening phase and meet all requirements, you will be enrolled into the study.  You will take rucaparib twice daily for treatment cycles of 28 days each.  During the first treatment cycle, you will have to return to the study center at about half way through the cycle and then again at the end of the cycle.  After the first cycle is completed, you will need to return to the study center approximately once every 4 weeks.  You can continue with additional treatment cycles for as long as the study doctor thinks it is in your best interest.  After you finish study treatment with rucaparib, you will need to complete an end of study treatment visit and then return to the clinic 28 days later for an end of study visit.

Principal Investigator:    Dr. Mark A. Morgan

 

UPCC: 24813:   A Phase 1, Open-Label  Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL. 

PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response. This study will evaluate the safety and tolerability of escalating doses of PEK fusion protein vaccine (PEK+GPI-0100) administered at one-week intervals by subcutaneous (sc) injections.  Expectation of the total duration of the study is 6 months. Individual patient participation is approximately 10 weeks inclusive of screening and follow-up. 

Principal Investigator:   Dr. Janos Tanyi 

Recurrent Ovarian Cancer

UPCC: 19809: A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded with Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube cancer.

This is a three cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide.  Study duration is 24 months. Study Sponsor: Dr. George Coukos.  Principal Investigator: Dr. Janos Tanyi

UPCC 26810: A Phase-I Trial of Adoptive Transfer of Vaccine-Primed CD3/CD28 Costimulated Autologous T-Cells Combined with Vaccine Boost and Bevacizumab for Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer Previously Vaccinated with Autologous tumor Vaccine.

 This is a phase-I clinical trial to determine the feasibility and safety of cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T cells, followed by vaccination with OC-DC, an autologous dendritic cell (DC) vaccine loaded with autologous oxidized tumor cells, administered intradermally followed by Bevacizumab in patients with recurrent ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent induction vaccination with whole tumor vaccine (UPCC 19809; UPenn IRB# 810271;) or (UPCC 29810; Penn IRB # 812800).  Study Sponsor: Dr. George Coukos. Principal Investigator: Dr. Janos Tanyi

Platinum Resistant Ovarian Cancer

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 candidates for standard treatment. Principal Investigator: Dr. Dan Sterman, Co-Principal Investigator: Dr. George Coukos

  • For more information about our GOG clinical trials in gynecologic oncology, please call 215-614-0234 or email ybarrac@obgyn.upenn.edu

  • For more information about our ovarian cancer immunotherapy clinical trials in gynecologic oncology, please contact our Clinical Team 215-615-7447 or email OCRC.Trials@uphs.upenn.edu

Maternal Fetal Medicine


Motherhood and Microbiome Study

The Motherhood and Microbiome Study (M&M) is sponsored by the National Institute of Nursing Research. The main goal of the M&M study is to figure out how different bacteria in the vagina might put women at risk for preterm birth.  Preterm birth occurs in over 12% of all pregnant women.  Infants born preterm are at risk for many problems during their life.  Women who have had prior preterm birth are at increased risk of having another baby preterm.  While there are some clinical interventions that you will be offered to reduce this risk, these do not work for all women.  Participation in this study will significantly help us understand why some women have recurrent preterm birth and may demonstrate potential therapies that might reduce the risk of preterm birth.

Principal Investigator: Dr. Michal Elovitz

NICHD Nulliparous Outcomes Study:  Monitoring Mothers-to-be (nuMoM2b)
The goals of this study are to determine maternal characteristics that influence or predict Adverse Pregnancy Outcomes (APOs,) identify aspects of placental development that lead to APOs, and characterize genetic, growth, and developmental elements of the fetus associated with APOs.  First-time mothers who have a singleton pregnancy (not pregnant with twins), are less than 14 weeks pregnant, and plan to deliver within the Penn Health system are eligible to participate.  Eligible women will come to a site at University of Pennsylvania or Pennsylvania Hospital 3 times throughout their pregnancy to answer surveys, have blood drawn, and have ultrasound exams.  Additional samples may be collected at delivery.  Principal Investigator:  Dr. Samuel Parry

  • For more information about our clinical trials in maternal fetal medicine, please call 215-662-7727 or send an email to reproresearch@obgyn.upenn.edu

Urogynecology

Refractory Overactive Bladder: Sacral Neuromudulation v. Botulinum Toxin Assessment (ROSETTA)

The purpose of this randomized, open label, active-control trial is to compare the effectiveness of an experimental treatment, botulinum toxin A (BOTOX) versus standard of care sacral neuromodulation (INTERSTIM) for the treatment of urge urinary incontinence (UUI). This study will look at women with refractory and severe UUI i.e. women who have failed conservative management and have at least 6 episodes of UUI on the bladder diary.  Effectiveness data will be collected at 3, 6, 12, and 24 months after the intervention. Principal Investigator: Dr. Lily A. Arya
 

A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy with Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension (SUPeR)Pelvic Floor Disorder Network

Uterovaginal prolapse happens when the uterus and vaginal wall bulges into or through the opening of the vagina.  Women with prolapse can often feel a bulge at the vaginal opening; we call this feeling having “bulge symptoms.”  A physician can choose from different types of vaginal surgery to repair uterovaginal prolapse, but we don’t have enough information about which surgery provides the best symptom relief while causing the fewest problems (complications) after surgery. Often, both surgeries are combined with repairs of the front (anterior or bladder side of the vagina) and back (posterior or rectal side) sides of the vagina.  This study will compare two kinds of repairs: 

  • One type of repair involves removing the uterus (hysterectomy).  The vagina is then re-supported with sutures to the ligaments that were previously attached to the uterus (uterosacral ligaments). This procedure is called a vaginal hysterectomy and uterosacral ligament suspension (USLS). 
  • The other type of repair is to leave the uterus in place, but just re-support the uterus (hysteropexy).  The Uphold Vaginal Support System is an Intra-Vaginal approach to prolapse that utilizes a small incision and mesh only where it’s needed, and is designed to reduce the risk of erosion.

Randomized trials of these 2 surgeries performed with long‐term follow‐up, are needed to evaluate the safety and effectiveness of these two procedures.  Patients and Study Coordinators will be masked or blinded throughout the duration of this study. Surgeons and anatomical evaluators will remain unmasked.  Principal Investigator: Dr. Lily Arya

Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM)  Pelvic Floor Disorder Network

ESTEEM is a 3-stage, multi-center randomized trial of 472 women with MUI who have elected to undergo surgical treatment for SUI. Participants will be randomized to a peri-operative BPTx program+MUS versus MUS alone.  The purpose is to compare combined  MUS+BPTx versus MUS alone (control) on improving MUI symptoms at 1 year.

  • Stage 1: preoperative BPTx versus control
  • Stage 2: all participants will undergo a MUS 
  • Stage 3: postoperative BPTx versus control  (based on initial randomization)

Principal Investigator: Dr. Lily Arya

Controlling Anal incontinence by Performing Anal Exercises with Biofeedback or Loperamide (CAPABLe): a randomized placebo controlled trial

Pelvic Floor Disorder Network

Approximately 294 women will be participating in the this study at 8 different hospitals and medical centers throughout the United States and about 37 women will be asked to participate at The University of Pennsylvania.  The goals of this trial are: to compare the use of loperamide to oral placebo,  to compare the use of anal sphincter exercises with biofeedback to sham exercises in the treatment of women suffering from fecal incontinence (FI). This study will use a factorial design that allows us to compare both of these first-line treatment options to placebo/sham in a single population, thereby improving efficiency and reducing cost.  Moreover, a factorial design may allow us to evaluate the value of combination therapy compared to single therapy.

Principal Investigator: Dr. Lily Arya

Family Planning

Miscarriage Management Choice

Using a sample of 60 qualitative interviews, we aim to uncover the factors that drive both patient decision-making as well as provider counseling about treatment decisions for miscarriage. The data will be utilized to develop a pilot decision aid that highlights the trade-offs that accompany the different management options in context of the patient's priorities. We will recruit a total of 45 patients from Penn Medicine, who have experienced uterine aspiration, medical management, or expectant management of early pregnancy failure. In addition, we will recruit 15 providers from Penn Medicine OB/GYN practices to participate in the open-ended interviews. Principal Investigator:  Dr. Courtney Schreiber

 

Comparative Effectiveness of Pregnancy Failure Management Regimens (Prefair)

This is a pivotal, multicenter (Phase III), randomized, controlled, trial comparing the efficacy of mifepristone (200mg) administered orally for premedication in office followed by vaginal misoprostol (800 µg) self-administered at home 24 hours later with vaginal misoprostol (800 µg) alone for early pregnancy failure.  Mifepristone and misoprostol are already used together successfully to induce tissue passage in women desiring induced abortion in early pregnancy.  This investigator-initiated, NIH-funded, trial will also test the ability of trophoblastic and endometrial biomarkers to predict which women are most likely to succeed with medical management of early pregnancy failure and to derive and internally validate a prediction model designed to guide individualized counseling and treatment for early pregnancy failure.  The following outcomes will be evaluated:

  • Success rates between study arms for early pregnancy failure
  • Side effect frequency, participant satisfaction, and acceptability of the treatment regimens
  • Cost analysis to compare these two treatments

Eligible participants will be healthy woman 18 years or older, between 5 and 12 weeks pregnant, and diagnosed with early pregnancy failure.  Additionally, potential subjects must opt for medical management to help pass the pregnancy, and be willing to be randomized to one of the two treatment arms.  Our proposed recruitment goal is 300 (150 women from Penn Medicine and 150 women from UC Davis).  Subject participation will last for 30 days.  Principal Investigator: Dr. Courtney Schreiber

Studies for Menopausal Symptoms  

Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study

This is a small clinical trial to assess if vilazodone (an SSRI) reduces the frequency and severity of menopausal hot flashes. Women aged 45-60 who have gone at least 60 days without a period in the last year and who experience bothersome hot flashes daily are invited to participate. Eligible participants will be randomized to 8 weeks of treatment with vilazodone or placebo. An additional aim is to identify improvement in menopause-related quality of life. Outcome assessments are the frequency and severity of hot flashes and clinical improvement. Approximately 30 women will be enrolled at the University of Pennsylvania. Principal Investigator: Dr. Ellen W. Freeman

  • For more information about studies for menopausal symptoms, please call Women's Health Research, Mudd Suite, 215-662-3329 or 1-800-662-4487

Women's Behavioral Wellness

Depression and Pregnancy Research Study
Are you pregnant and suffering from depression?  Are you looking for a non-medication based treatment to help with your symptoms?  The goal of this study is to investigate a new treatment for depression during pregnancy called Transcranial Magnetic Stimulation (TMS).  TMS is a non-invasive method used in the treatment of depressive symptoms.  TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another.  Effective neuron communication leads to lessening of depressive symptoms.  TMS requires daily (Monday through Friday) treatment for approximately 4 weeks.

Principal Investigator:  Dr. Deborah Kim

Clinical Research Coordinator: Lisa Lamprou

Telephone: 215-573-8880

Email: llamprou@upenn.edu  

Smoking and the Female Brain
Healthy women who smoke at least 1 pack of cigarettes a day are needed to participate in a paid brain imaging study.  While you do not have to be ready to quit smoking to participate in this study, information on how to quit will be provided.  The purpose of this study is to learn more about the effects of nicotine on brain chemicals and how they may differ between men and women.  PCWBW is seeking women and men 18-50 years old who are in good physical and smoke at least 1 pack of cigarettes per day.  

Principal Investigator: Dr. C. Neill Epperson

Clinical Research Coordinator: Claudia Schinstine

Telephone: 215-573-8878

Email: sclaud@upenn.edu  

Menopause & Memory Study

Have you ever walked into a room and couldn’t recall what you went there for?  Do you forget something if you don’t write it down?  Do you find yourself having to read the same page of a book over and over again?  These are common complaints reported by women as they progress through the menopause.  For some women, these changes in cognition can be very frustrating and affect their sense of well-being.  Our Center is studying whether a medication that is typically used to treat individuals with attention deficit disorder can improve memory, focus, and attention in menopausal women. Principal Investigator: Dr. C. Neill Epperson

Clinical Research Coordinator: Jeanette Bradley

Telephone: 215-573-8884

Email: jbradl@upenn.edu  

Estrogen, Serotonin and Memory in Menopause

The purpose of this study is to look at how estrogen affects memory, emotions, and brain activity in menopausal women.  The length of time you'll be on estrogen or placebo is approximately 10 weeks.  This is also a brain imaging study in which you will participate in 4 fMRI scans; 2 before beginning estrogen or placebo treatment and 2 after starting estrogen or placebo treatment.  PCWBW is looking for women who are peri- or post-menopausal, non-smokers, and not taking hormones, including birth control pills. Principal Investigator: Dr. C. Neill Epperson

Clinical Research Coordinator: Claudia Schinstine

Telephone: 215-573-8878

Email: sclaud@upenn.edu

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