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Studies/Clinical Trials

Diagram of a uterus and ovaries

Endometriosis Research Study

Drs. Minda Green and Ryan Offer are currently recruiting patients for a Phase 3 study to evaluate the safety and efficacy of Elagolix 200 mg oral drug (BID) in combination with estradiol 1.0mg/norethindrone acetate 0.5mg (QD) in subjects with moderate to severe endometriosis-associated pain.

This is a three-year study with 24 months of treatment and 12 months follow up. The first 12 months of the treatment period will employ a randomized, double-blind, placebo-controlled design. The next 12 months will be open-label, such that all subjects will receive active treatment.

Eligibility

Participants must (at a minimum):

  • Be premenopausal women between the ages of 18 and 49
  • Have a clinical diagnosis of endometriosis by means of documented surgical visualization within the
    past 10 years
  • Agree to use two forms of non-hormonal contraception
  • Not be currently pregnant or breastfeeding or planning a pregnancy during the duration of the study
  • Not have a history of:
    • Depression, PTSD and/or suicide attempts
    • Osteoporosis or any metabolic bone disease or condition that would interfere with obtaining adequate DXA measurements (spinal surgery, severe scoliosis or weight, low-trauma hip or vertebral fractures)
    • Deep vein thrombosis or pulmonary embolism
    • Arterial thromboembolic disease (stroke, myocardial infarction)
    • Chronic pelvic pain that is not caused by endometriosis

Eligible women will receive study related exams and medication as well as compensation for their time for each visit or procedure.

Learn More or Enroll in the Study

For more information, or if you think you or a patient might be eligible, please contact Marisol Burgos Norwood or Kate McCreary at 215.762.7442.

Enrollment ends on January 31, 2019.


Uterine Fibroid Treatment Study

Dipak Delvadia, DO, is currently recruiting patients for participation in a study to assess the safety and efficacy of Vilaprisan in subjects with uterine fibroids compared to standard of care.

This is an open-label, parallel-group, randomized, multicenter study. It will take between two and three years with multiple office visits, ultrasounds, bone mineral density scans and electronic diary completion.

Eligibility

Participants must (at a minimum):

  • Be 18 years or older
  • Have a diagnosis of uterine fibroids as documented by ultrasound or are high risk for recurrence
  • Currently be having one or more of the following symptoms:
    • Heavy menstrual bleeding
    • Pelvic pressure or pain associated with uterine fibroids
  • Not be pregnant or breastfeeding
  • Be using an acceptable nonhormonal method of contraception

Eligible women will receive study-related exams and medication as well as compensation for their time for each visit or procedure.

Learn More or Enroll in the Study

For more information, or if you think you have a patient who might be eligible, please contact Marisol Burgos at 215.762.7442 or mb334@drexel.edu.


Ovarian Reserve Study

Karen Berkowitz, MD, a reproductive endocrinologist and infertility specialist, and her group in the Drexel Departments of Obstetrics & Gynecology and Biochemistry & Molecular Biology are conducting a research study to identify new biomarkers of ovarian reserve in women. The research aims to advance women's health with a focus in the area of female fertility and to provide women with information to help them make proactive choices about their reproduction. This research has the potential to help the current and next generations of women!

Eligibility

Participation eligibility includes:

  • Age 30–45
  • Regular periods
  • History of at least one birth
  • Not taking hormonal contraceptives or hormones for at least two months (copper IUD okay)

This study is currently recruiting women from the Feinstein and 17th Street patient practices, Drexel/HUH employees, and those referred by word-of-mouth. There is no cost and the study only involves a single blood draw on the second, third or fourth day of the period.

Learn More or Enroll in the Study

Email ovarianstudy2017@gmail.com or call/text 267.702.4616 for more information or to enroll in the study.

The images being used are for illustrative purposes only; any person depicted is a model.

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