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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00437658
Eligibility Criteria:
Inclusion Criteria:
* Be female, aged 18 to 49 years, inclusive
* Have a total CPSSS of ≥ 6 at screening and baseline (Day 1) in the following categories: dysmenorrhea, dyspareunia, nonmenstrual pelvic pain, pelvic tenderness and induration. The total score must include a total of at least 2 in each of the categories of dysmenorrhea and nonmenstrual pelvic pain.
* Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within 8 years of the start of screening with recurrent or persistent symptoms.
* Have documented negative mammogram results within 12 months of screening if over the age of 40 years.
* Have menstrual cycles (28 days ±5 days). Assessment of cycle duration should be based on observations in the absence of drugs or conditions that are known to affect the cycle (e.g., oral contraceptives, leuprolide, pregnancy).
* Have a Body Mass Index (BMI) between 18 and 36 kg/m², inclusive.
* Agree to use two forms of nonhormonal contraception (e.g. condom with spermicide) during the study.
Exclusion Criteria:
* Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
* Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
* Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
* Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 1 month of the start of screening.
* Have had surgical treatment for endometriosis (laparoscopy) within 1 month of the start of screening.
* Have had a hysterectomy or bilateral oophorectomy.
* Have had prior treatment with NBI-56418.
* Have uterine fibroids or other pelvic lesions ≥ 5 cm in diameter
* Have any of the following abnormal cervical smear results at screening (based on the 2001 Bethesda System):
* Benign endometrial cells (BEC) present, provided subject has irregular uterine bleeding or is over 40 years old
* Atypical squamous cells of undetermined significance (ASC-US) present, and human papilloma virus (HPV) reflex testing is positive for high risk types or the testing outcome is unknown
* Atypical squamous cells present, and high-grade squamous intraepithelial lesion (ASC-H) cannot be excluded
* Atypical glandular cells of uncertain significance (AGUS/AGC): not otherwise specified (NOS), favor neoplasia (FN), favor endocervical, or favor endometrial origin types
* Low-grade squamous intraepithelial lesion (LSIL) present
* High-grade squamous intraepithelial lesion (HSIL) present
* Adenocarcinoma in situ (AIS) / malignant cells present
* Have BMD with either lumbar spine or femur T-scores below -1.5 at screening as determined by the central DXA facility or have history of pathologic or compression fractures.
* Have been pregnant within 6 months of screening or currently breast feeding
* Are using systemic steroids on a chronic or regular basis within 3 months
* Have unstable medical condition or chronic disease
* Have chronic pelvic pain that is not caused by endometriosis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT00437658
Study Brief:
Protocol Section:
NCT00437658