Full Name
Andrea Lukes
Job Title
Chief Medical Officer,
Health Decisions
Speaker Bio
Dr. Andrea S. Lukes is a board-certified OB/GYN, a Fellow of The American Congress of Obstetricians and Gynecologists and an expert on clinical development of women’s health products across a wide range of indications across the female lifecycle. Her areas of expertise include but are not limited to endometrial ablation, endometriosis, hysteroscopy, minimally invasive gynecology, bleeding disorders, uterine fibroids, contraception, menopause and vasomotor symptoms, hereditary cancer screening and prenatal counseling. Dr. Lukes advises Health Decisions and our clients on development and implementation of research protocols as well as communications and presentations to the FDA.

An experienced principal investigator in industry-sponsored, NIH and CDC clinical trials, Dr. Lukes has conducted or overseen more than 90 clinical trials of investigational women’s health products, including both drugs and devices. Recent experience includes studies of sedation during hysteroscopic tissue removal, treatment of anemia associated with uterine leiomyomas, treatment of vulvovaginal atrophy, transcervical ablation of uterine fibroids, combination drug therapy for management of menstrual bleeding associated with uterine fibroids in premenopausal women, a vapor treatment for excessive uterine bleeding, analgesia for endometriosis-associated pain, pain management during endometrial biopsy, and migraine.

Dr. Lukes’ articles have appeared in journals including Obstetrics and Gynecology, the American Journal of Obstetrics and Gynecology, Fertility and Sterility, the Journal of Minimally Invasive Gynecology, Women’s Health, Women’s Healthcare, Contemporary OB/GYN, the International Journal of Women’s Health, Cancer, the British Journal of Hematology, the Journal of Medicine, Current Medical Research & Opinion and Drug Safety. She has served on advisory committees for FDA meetings on topics including a clinician’s perspective on thromboembolism, heavy menstrual bleeding and alkaline hematin assessment, and clinical trial design for treatment of vaginal laxity and female sexual dysfunction.

Dr. Lukes founded the Carolina Women’s Research and Wellness Center (CWRWC), a leading private gynecologic practice and clinical research center. She also co-founded and served as the Director of Gynecology for the Women’s Hemostasis and Thrombosis Clinic at the Duke University Medical Center and founded and chaired the OB/GYN Alliance, an online network of 8,000 OB/GYN physicians in the United States.

Dr. Lukes received a bachelor’s degree and a combined medical degree and master’s degree in statistics from Duke University. She completed her residency at the University of North Carolina School of Medicine.
Andrea Lukes