This study is being conducted at 160 research centers in the United States and Puerto Rico. Approximately 800 volunteers with moderate-to-severe endometriosis-associated pain will participate in this study.
The study doctor will determine your eligibility if you agree to be in this research study. You may also be asked about your medical history, undergo medical tests (such as physical examinations, blood work, urine analysis, etc.), and complete questionnaires as part of your study participation. Please note that you will also be asked to complete X-ray absorptiometry (DXA) scans that measure your bone mineral density throughout the study.
Eligible participants will be assigned randomly to receive either the oral investigational medication or placebo in addition to a combined oral contraceptive or placebo once a day for three months. To prevent any biases from affecting the results, participants, the study doctor, and the study staff won’t know which study treatment selection you’ve received. However, this information will be available in the event of an emergency. During these three months, you can take additional study-allowed pain medication prescribed by your study doctor, if necessary, for your endometriosis pain (known as “pain rescue medication). After this initial three-month period, all subjects will receive the active oral investigational drug (no placebo) plus the combined oral contraceptive, both taken once a day.
The combined oral contraceptive contains both estrogen and progesterone medication. It has been approved by the U.S. Food and Drug Administration (FDA) as a method of contraception. The investigational medication has been FDA-approved for moderate-to-severe pain associated with endometriosis. However, the investigational medication is not approved for use with a combined oral contraceptive. Therefore, this study will determine whether using the investigational drug and the oral contraceptive together is safe and effective.
Participation in this study will last approximately 21 to 45 months, with 14 study visits to the research center and ten phone visits.