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 Research

Obstetrics and gynecology (OB/GYN) clinicians representing all subspecialties conduct research both at the UH Landerbrook Health Center outpatient facility and at University Hospitals MacDonald Women's Hospital. Research coordinators are available to assist basic scientists in the following ways:

  • Protocol development
  • Provide clinical support for the collection of research data
  • Submission of human subject protocols for institutional review and recruitment of subjects

Pilot Studies through MacDonald Clinical Trials Unit

Pilot studies conducted through the MCTU include research on:

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

Sexual Dysfunction Clinical Trials Specialization

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.

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

Dedicated Clinical Trials for Pharmaceutical Research

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 more than 70 trials, including:

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

Nursing Core

The MCTU at UH 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 Research Projects

James Liu, MD

  • NIH Contraceptive Center
  • Pulsatile GnRH for Ovulation Induction
  • Selective Progesterone Receptor Modulators for Treatment of Fibroids (SPARM)
  • TV Ultrasound-guided High-Intensity Focused Ultrasound for Treatment of Myomas

Angelina Gangestad, MD

  • Contraceptive Patches
  • Oral GnRH antagonist for Endometriosis
  • Oral GnRH antagonist for Uterine Fibroids
  • Vaginal Microbicide for HIV

Sheryl Kingsberg, PhD

  • Melanocortin Receptor Agonist for Female Sex Drive
  • SSRI for Sexual Dysfunction

Sangeeta Mahajan, MD

  • Botox for Bladder Dysfunction

To Learn More about Obstetrics, Gynecology and Reproductive Biology Research

For more information, contact James H. Liu, MD, Director and Angela K. Gangestad, MD, Co-Director.

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