UC Health Reproductive Medicine Research (RMR) is the research center serving the Division of Reproductive Endocrinology and Infertility in Department of Obstetrics and Gynecology at the University of Cincinnati. Since the center’s inception in 1988, it has been a stand-alone research facility for conducting outpatient clinical trials specific to women’s health.
Celebrating over 20 years of operation, UC Health Reproductive Medicine Research is committed to innovative scientific research for women. Major areas of research include: gynecology (contraception, menstrual cramps, endometriosis, vaginal infection), menopause (osteoporosis, libido, vaginal atrophy, hormone replacement therapies) and infertility.
Currently under the direction of Michael A. Thomas, MD (Medical Director), and Rose A. Maxwell, PhD (Director of Clinical Trials), RMR provides the clinical infrastructure to support the research activities of the department’s faculty.
UC Health Reproductive Medicine Research is committed to conducting innovative scientific research to advance medical knowledge and treatments in women’s health. We provide quality research services in a patient-friendly atmosphere that serves both academic and industry needs.
Our investigators are members of the University of Cincinnati faculty and are nationally recognized for their research and practice in Obstetrics and Gynecology. Our commitment toward excellence in research is clearly demonstrated by the reputations of our physicians and by our well-trained staff.
UC Health Reproductive Medicine Research focuses specifically on research studies in women’s health. Throughout the past 20 years, we have conducted numerous research studies in the following areas:
- contraceptive devices and methods
- menstrual cramps
- heavy menstrual bleeding
- vaginal infections
- female sexual dysfunction, libido
- menopause (hot flashes, vaginal dryness)
Some of these studies have resulted in new treatment options for women that include: Fosamax (for prevention and treatment of osteoporosis), Novasure (an endometrial ablation system for treatment of heavy menstrual bleeding), low-dose Premarin, PremPro, Evista, Yasmin, Ortho Tri Cyclen, Ortho Tri Cyclen Lo, Mirena, a contraceptive vaginal ring, and other products.
UC Health Reproductive Medicine Research is located in the Holmes Hospital Building in Clifton across from the University of Cincinnati College of Medicine. The center is a stand-alone research facility that includes three exam rooms, seven coordinator offices, two conference rooms and a specimen processing lab. We have a digital colposcope, a refrigerated centrifuge, specimen refrigerator, -20° C freezer and access to a -70° C freezer and dry ice. In addition, we have six computers with Internet connection though a LAN and a document scanner.
UC Health Reproductive Medicine Research receives funding from federal and industry sources. As an academic health center, we actively write and receive grant funding from the National Institutes of Health (NIH). Under the local direction of Dr. Thomas, we participate in the contraceptive Clinical Trials Network, a network of 12 research centers funded by the National Institute for Child Health and Development (NICHD). Consistent with the academic mission of the University, we support many non-funded, Investigator-Initiated studies for our faculty and fellows.
Additional funding is received on a contracted fee-for-service basis for the pharmaceutical industry. We have worked with numerous industry sponsors including Agile Therapeutics, Ausio Pharmaceuticals, Bayer Healthcare, Boehringer-Ingelheim, Pfizer, CONRAD, Ferring, GlaxoSmithKline, Hermann-LaRoche, Hologic, Medicines 360, Merck, Neurocrine Biosciences, Novacept, Organon/Schering, Procter & Gamble, Serono, Wyeth and Xanodyne.
For more information or to see if you might qualify please contact our research staff at (513) 584-4100 or contact us by e-mail.
Seeking Healthy Women 18-35 to Test the Effects of an Investigational Pill on Ovulation and Menstrual Bleeding
What: The pill that will be used in this research study is experimental and being developed as a possible new method of birth control.
Who: Healthy women between the ages of 18 and 35 who have regular menstrual cycles
Agree to use an acceptable non-hormonal method of birth control during participation in the study
Must not be planning to become pregnant during the study
Can commit to a twice a week intensive visit schedule for 6 months
Pay: Participants will be paid for time and travel
Details: For more information call Deborah Boerschig at at 513-584-5361 or email Deborah.Boerschig@uc.edu
Not menstruating and not pregnant – Should I be concerned?
To qualify, you must be: Female between the ages of 18 and 40
Premenopausal with an intact uterus
In generally good health
Willing to participate in a clinical trial
If you qualify, you will receive at no charge:
Investigational study medication
Study-related medical exams
Call Tiffany Rupert for more information at 513-584-4130 or email Tiffany.Rupert@uc.edu
Has your sexual function been reduced by your birth control pill?
What: This is a research study to find out how effective a hormonal supplement is in improving sexual dysfunction resulting from the use of oral contraceptive pills.
Who: Healthy women 18-40 years old who are in a sexually active relationship currently with sexual dysfunction using oral contraceptive pills for at least 3 months.
Details: Call Jennifer Golan for more information at 513-584-4100 or email Jennifer.Golan@uc.edu
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Two Doses of Subcutaneous Pulsatile GnRH Administered via OmniPod Pump for Ovulation Induction in Female Subjects with Primary Amenorrhea with Hypogonadotropic Hypogonadism.
Study Seeking: Women between 18-40 years of age who have been diagnosed with Primary Amenorrhea with Hypogonadotropic Hypogonadism (HH), and have a desire to become pregnant.
Call Jennifer Golan for more information at 513-584-4100 or email Jennifer.Golan@uc.edu
Participating in a research study means that you can make a difference in the future of health care.
Drug research and development occurs in several phases, each with different goals for the developmental process.
Phase 1 Studies
Phase 1 studies are the first time an investigational drug is used in humans. Phase 1 studies are usually conducted in a small number of healthy volunteer subjects (typically between 20 and 80) and are closely monitored. The goals are to determine how the drug is absorbed and eliminated from the body, to determine a safe dose range for the drug and to gather information that will help researchers design a study for the next phase, Phase 2.
Phase 2 Studies
Phase 2 studies are the first examination of the effectiveness of an investigational drug for a particular condition. These studies are conducted in several hundred patients (200-300) who have the disease or condition. Phase 2 studies are typically well controlled and closely monitored to determine the preliminary effectiveness, short-term side effects and risks associated with the drug.
Phase 3 Studies
Phase 3 studies are performed if there is preliminary evidence of effectiveness for a particular condition (from Phase 2 studies). Phase 3 studies are needed to gather more information about a drug’s effectiveness, safety and appropriate dosage in different clinical settings. The goal is to evaluate the overall benefit-risk relationship (does the benefit outweigh the risks?) and to gather enough information for physicians and product labeling. Phase 3 studies are performed in a variety of clinical settings and in large numbers of patients (400-1,000s).
Once the sponsor has gathered enough information from carefully designed studies and is able to show that the drug is safe and effective, the sponsor applies to the FDA for approval to market the drug.
Phase 4 Studies
Phase 4 studies are after-market studies. The FDA may ask the sponsor to gather additional information about the drug. Phase 4 studies may focus on gathering additional information about the drug’s risks and benefits, different doses or dosing schedules, different patient populations, different stages of the disease or effects of the use of the drug over longer periods of time.
Through all phases of drug development, the Code of Federal Regulations provides sponsors and investigators with guidelines for research and development. Sponsors and investigators must abide by these regulations when conducting clinical trials. These guidelines dictate various requirements of research including the informed consent process, safety monitoring, quality of the data and many more.
This means that when you participate in a study all study procedures will be completely explained to you before you decide if you want to participate. All procedures that are performed for the study are at no cost to you and the results are closely monitored by the investigator. Your research records are confidential. You may be compensated for your time and travel.
Michael A. Thomas, MD
Dr. Thomas has been involved with the research center since its beginnings in 1988. He has participated in over 100 clinical trials, both NIH and industry sponsored, in his many years at the University of Cincinnati. Dr. Thomas has been the Medical Director of the research center for over 10 years.
Julie M. Sroga, MD
Dr. Sroga joined the University of Cincinnati faculty in 2012, after completing three years as a Reproductive Endocrinology & Infertility Fellow at the University of Cincinnati. Her research interests focus on polycystic ovarian syndrome, implantation, and oncofertility.
Krystene B. DiPaola, MD
Dr. DiPaola joined the University of Cincinnati faculty in 2010 after completing three years as a Reproductive Endocrinology & Infertility Fellow at the University of Cincinnati.
Rose A. Maxwell, PhD
Dr. Maxwell has served as Research Manager/Director of the research center since 2003 when she joined the Department of Obstetrics and Gynecology at the University of Cincinnati. Prior to that, Dr. Maxwell served as Statistician/Lab Supervisor for the Department of Psychiatry at UC.
She has over 20 years of experience in research with 14 years in clinical trials. She directs all activities within the Division of Clinical Trials for the Department of OB/GYN including study project management, regulatory and study coordinating. She has several publications in the areas of OB/GYN, psychiatry/addictions and social psychology. She earned a PhD in Social Psychology from UC in 1996.
Deborah Boerschig, CNP, CCRC
Ms. Boerschig has over 37 years of experience in nursing with 20 years as a Nurse Practitioner and over 10 years of experience in clinical research. Ms. Boerschig earned Clinical Research Coordinator Certification in 2003.
In her role as study coordinator, she has been involved in study screening/enrollment, performing all patient procedures within her scope of practice, completing Case Report Forms and maintaining regulatory files. She has assisted in protocol development for the Contraceptive Clinical Trials Network (CCTN, Principal Investigator: Michael Thomas, MD). She coordinates CCTN studies as well as a variety of industry-sponsored studies.
Ms. Rupert has over 5 years of clinical research experience. Ms. Rupert is involved in study screening/enrollment, performing patient procedures, completing Case Report Forms and maintaining regulatory files. She coordinates studies with Ms. Boerschig for the CCTN as well as coordinating a variety of industry-sponsored studies.