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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01968694
Eligibility Criteria:
Inclusion criteria:
* Reproductive age women ages 18 - 50
* Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist using clinical criteria
* Pain for \> 6 months
* Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.
* Receiving regular monthly menses (cannot be receiving Depo-provera injections)
Exclusion criteria:
* Pregnant or breastfeeding
* On lupron therapy
* History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
* History of seizure disorder
* Significant anxiety, psychosis or other cognitive disorder limiting completion of study procedures
* History of alcohol or substance abuse
* Chronic pain symptoms other than chronic pelvic pain (excluding migraine pain)
* Known hypersensitivity to amide type anesthetics
* Known hypersensitivity to diphenhydramine (benadryl)
* History of treatment with lidocaine or mexiletene
* Having or showing signs and symptoms of liver disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01968694
Study Brief:
Protocol Section:
NCT01968694