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Medicine

Reproductive Biology

Clinical Trials Group

Clinical Trials Group

The MacDonald Clinical Trials Unit (MCTU) was established in 2002 to conduct industry supported pharmaceutical drug trials in women’s health and to support physician-initiated clinical research within the department. Since its inception the MCTU has established a strong reputation as a regional leader in the conduct of pharmaceutical trials in women’s health. Obstetrics and Gynecology (Ob/Gyn) clinicians representing all subspecialties conduct research both at the Landerbrook outpatient facility and at MacDonald Women’s Hospital. Research coordinators are available to assist basic scientists with protocol development; submission of human subject protocols for institutional review and recruitment of subjects; and also to provide clinical support for the collection of research data. Pilot studies conducted through the MCTU include research on:

  • The effects of chemotherapy on ovarian cancer
  • Hormonal control of vaginal multidrug resistance receptors
  • The biochemistry of the myometrium during labor and delivery

The MacDonald Clinical Trials Unit has also been a leading site in a number of clinical trials designed to assess the safety and efficacy of investigational drugs designed to treat the loss of sexual desire in women.


Personnel

The Director of the MCTU is Dr. James Liu, Chair of the department. Dr. Liu has extensive experience in pharmaceutical-oriented research trials having conducted over 70 trials. This includes:

  • Trials of contraceptive steroid rings;
  • Low-dose, third-generation progestin oral contraceptives;
  • Progestin-only contraceptives;
  • SERM;
  • SPARMs;
  • Hot flush;
  • Estrogen gels;
  • The effects of GnRH agonist on endometriosis;
  • The use of erythropoietin in uterine myoma and hysterectomy; and
  • Use of the cervical cap.

More recently, Dr. Kingsberg has spearheaded trials targeted to increase female sexual desire in women with sexual dysfunction.

The MCTU at MacDonald Women’s Hospital is staffed by highly qualified and experienced clinical research coordinators. The Nursing Core consists of a full-time certified nurse midwife and two full-time RNs. Lisa Wolfe, RNP, has been with the MCTU since 2004 and is responsible for aspects of ongoing clinical research projects—including protocol planning, implementation, and documentation of study activities.


Current Projects

  • James Liu, MD
    • NIH Contraceptive Center;
    • Selective Progesterone Receptor Modulators for Treatment of Fibroids (SPARM);
    • Pulsatile GnRH for Ovulation Induction; and
    • TV Ultrasound-guided High-Intensity Focused Ultrasound for Treatment of Myomas.
  • Angelina Gangestad, MD
    • Contraceptive Patches;
    • Vaginal Microbicide for HIV;
    • Oral GnRH antagonist for Uterine Fibroids; and
    • Oral GnRH antagonist for Endometriosis .
  • Sheryl Kingsberg, PhD
    • SSRI for Sexual Dysfunction and
    • Melanocortin Receptor Agonist for Female Sex Drive.
  • Sangeeta Mahajan, MD
    • Botox for Bladder Dysfunction

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