The NOTE Study
Novel Treatments for Endometriosis
Researchers at Boston Children’s Hospital (in collaboration with Thomas Jefferson University, Beth Israel Deaconess Medical Center, Children’s Hospital Colorado, and Stanford University) are conducting a study on endometriosis for people who are using hormonal medication but still have pelvic pain.
Fast Facts
Surgically Confirmed Endometriosis
15-40 Years Old
Assigned Female at Birth
Compensation Provided
3 Study Visits Over 6 Months
Study Background
Does adding cabergoline to standard treatment decrease pain associated with endometriosis?
The NOTE (Novel Treatments for Endometriosis) Study is looking for participants who have surgically confirmed endometriosis, who are experiencing pain, and who are using birth control pills, norethindrone acetate, or have a hormonal intrauterine device (IUD). This research study is investigating whether an existing non-hormonal medication is beneficial for pain relief in endometriosis. If you are interested in trying an investigational medicine to help with your pain, you could be a good fit for the NOTE Study.
Cabergoline is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of other medical conditions. In this study, the use of cabergoline is investigational. This means the drug is not approved by the FDA for the treatment of endometriosis.
Study Background
Does adding cabergoline to standard treatment decrease pain associated with endometriosis?
The NOTE (Novel Treatments for Endometriosis) Study is looking for participants who have surgically-confirmed endometriosis, who are experiencing pain, and who are using birth control pills, norethindrone acetate, or have a hormonal intrauterine device (IUD). This research study is investigating whether an existing non-hormonal medication is good for a new use in endometriosis. If you are interested in trying an investigational medicine to help with your pain, you could be a good fit for the NOTE Study.
Cabergoline is a medication that is approved by the Food and Drug Administration (FDA) for treatment of other medical conditions. In this study, the use of cabergoline is investigational. This means the drug is not approved by the FDA for the treatment of endometriosis.
Additional Information
In this research study, we want to learn more about a potential new therapy for pain associated with endometriosis. We want to determine if a non-hormonal medication, cabergoline, will help patients with endometriosis.
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- 15-40 years old
- Assigned female at birth
- Surgically confirmed endometriosis
- Currently using the same hormonal medication (birth control pill, progestin-only pill, hormone-containing IUD) for at least 2 months
- Experiencing pelvic pain
- Speak English
- Have had first period & have not completed menopause
Exclusion Criteria:
- Pregnant, breastfeeding, postpartum, or planning to become pregnant in the near future
- History of significant heart, liver, or blood conditions
- Significant mental or chronic illness that affects the ability to rate endometriosis pain
- Taking drugs that affect dopamine (e.g., phenothiazines, butyrophenones, thioxanthenes, and metoclopramide)
- Make 3 visits to one of our research sites over 6 months
- Give blood and urine samples and have vital signs measured at each visit
- An external ultrasound of blood vessels (only for Boston participants)
- Complete questionnaires about your physical and emotional health at each visit
- Have sensory testing performed at each visit
- Complete a daily symptom diary
- Complete 2 phone calls between visits at 6 weeks and 18 weeks
- Take a study medication twice per week for six months. Participants will be randomized (chosen by a flip of a coin) to either receive cabergoline (the study medication) or a placebo pill (a sugar pill) for 6 months.
As a participant, you can receive up to $225 for your time and effort. Parking or $10 cash compensation for public transportation is also provided.
There is no cost for you to participate. All study-related expenses, such as research visits and study medication, will be covered by the study.
