Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT04527003
Eligibility Criteria:
Inclusion Criteria:
1. Females ages 18-45 years at the time of enrollment
2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis with associated moderate to severe endometriosis related pain ( \> 3 on a VAS)
3. Is not expected to undergo gynecological surgery or other surgical procedure for treatment of endometriosis during the study period
4. Agrees to use approved contraception during the entire study if not surgically sterile
5. Patients using oral contraceptives, vaginal ring, injectable progesterone and/or GnRH agonists/antagonist for contraception and/or management of endometriosis, can be included if both they and their primary provider agree to stopping their medication and transitioning to Norethindrone acetate (NETA) as the primary treatment of endometriosis throughout the study period.
6. Patients using Long-acting reversible contraceptives (LARCs) for contraception and/or management of endometriosis can be included if both they and their primary provider agree to initiate Norethindrone (NETA) as the primary treatment of endometriosis throughout the study period
Exclusion Criteria:
1. Women that are pregnant, breastfeeding or trying to conceive
2. Women with chronic daily opioid use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids for \> 14 days per month.
3. Women that are currently using Cannabis based products or have used them within 30 days of enrollment
4. Non-English speaking or inability to read and understand English
5. Women with a BMI \> 35 kg/m2
6. Women with known liver disease, such as hepatitis, or with screening LFTS (AST/ALT) \> 3 times above the upper limits of normal (ULN) in the past year
7. Women with chronic alcohol use (defined as \> 3 drinks per day, averaged over one week)
8. Women with chronic use of drugs (defined as \> 10 days/month) that cause somnolence/sedation such as benzodiazepines or Central Nervous System (CNS) depressants that are unwilling or unable to discontinue the medications for the washout period and the duration of the study
9. Women who are currently taking Clobazam or Valproate and are unwilling/unable to discontinue the medication for the washout period and the duration of the study
10. Women with suicidal ideation or uncontrolled depression within the past year
11. Known history of or suspected breast cancer on screening physical exam
12. History of or active deep venous thrombosis or pulmonary embolism
13. History of or active arterial thromboembolic event (e.g. stroke, myocardial infarction)
14. Multiple (\> 3) risk factors for arterial vascular disease (e.g. uncontrolled hypertension, diabetes mellitus, hypercholesterolemia, obesity and smoking)
15. Current use of a progestin-containing contraceptive implant
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04527003
Study Brief:
Protocol Section:
NCT04527003