AbbVie M12-817 Study
A phase 3 study to evaluate the efficacy and safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
The University of Pennsylvania is conducting a research study evaluating the safety and effectiveness of an investigational medication for women with uterine fibroids and heavy menstrual bleeding. If you are a woman between the ages of 18 and 51 and have heavy bleeding due to uterine fibroids, you may qualify to participate.
Women in this study will be asked to take the investigational study medication for 6 months. Participation may be up to 21 months in total. Qualified individuals will receive the investigational study medication, study-related medical exams, and laboratory services at no charge. They will also receive compensation for time and travel.
Individuals may qualify if they:
are female, 18 to 51 years of age
have been diagnosed with uterine fibroid(s)
experience heavy menstrual bleeding
are in good general health
are not using hormonal contraceptives or seeking pregnancy
are not using or are willing to stop other treatments (including hormonal contraceptives or hormonal medications) for heavy menstrual bleeding
Closed to recruitment
Principal Investigator: Dr. Suneeta Senapati, MD, MSCE
For more information and to see if you qualify, contact the study coordinator: