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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02523794
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women, 16 to 49 years of age
* Diagnosed with endometriosis by means of documented surgical visualization (laparoscopy or laparotomy) within 10 years of study entry
* No endometriosis-related surgical procedures within a month of starting study agent
* Has at least 2 days of moderate or severe pain scores for dysmenorrhea (E-diary NRS \> 5 of 10) and non-menstrual pelvic pain (E-diary NRS \> 5 of 10) during the month prior to starting study agent
* Must have had a menstrual cycle of interval 24-35 days within 3 months of starting study agent
* BMI 18 to 39
* Able to provide written informed consent and able to comply with study procedures for the entire length of the study
Exclusion Criteria:
* Pregnant or breastfeeding or planning pregnancy in the next 12 months
* Has been pregnant within 3 months of starting study agent
* Has had a hysterectomy or bilateral oophorectomy
* Has chronic pelvic pain not caused by endometriosis (i.e. inflammatory bowl disease, irritable bowel syndrome, adenomyosis, interstitial cystitis, pelvic adhesive disease, pelvic inflammatory disease) that requires chronic analgesic or narcotic use which would interfere with assessment of endometriosis associated pain
* Current history of undiagnosed abnormal uterine bleeding
* Currently receiving Gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these types of medications within 6 months of starting study agent
* Currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or i.m. medroxyprogesterone acetate (DMPA-IM) or have received any of these within the last 3 months of enrollment
* Currently has an intrauterine device in place
* Use of steroids or immunosuppressive medications on a regular basis within 3 months of enrollment
* Has an unstable medical condition, chronic disease or psychiatric disorder that is deemed by the investigator to be incompatible with participation in the study
* Treatment with any other investigational drug/interventions within 3 months of starting study agent
* History of drug or alcohol abuse
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
49 Years
Study:
NCT02523794
Study Brief:
Protocol Section:
NCT02523794