Clinical trial NCT00437658 (phase 2, status: completed)
Conditions: endometriosis
ICD codes: N80.8, N80.9, N80.0, N80.1, N80.5, N80.2, N80.3
Drugs: elagolix, subcutaneous depot medroxyprogesterone acetate (dmpa-sc), placebo to elagolix, placebo to dmpa-sc
SMILES: COC1=C(F)C(=CC=C1)C1=C(C)N(CC2=C(C=CC=C2F)C(F)(F)F)C(=O)N(C[C@H](NCCCC(O)=O)C2=CC=CC=C2)C1=O, [H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)CC[C@]12C, COC1=C(F)C(=CC=C1)C1=C(C)N(CC2=C(C=CC=C2F)C(F)(F)F)C(=O)N(C[C@H](NCCCC(O)=O)C2=CC=CC=C2)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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