Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

NCT ID: NCT00437658

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-11
• Study Completion Date: 2008-11-24

Brief Summary

This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Elagolix 75 mg BID

Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.

Group Type: EXPERIMENTAL

Elagolix

Intervention Type: DRUG

Provided as tablets for oral administration

Placebo to DMPA-SC

Intervention Type: DRUG

Matching placebo for subcutaneous injection in a pre-filled syringe

Elagolix 150 mg QD

Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.

Group Type: EXPERIMENTAL

Elagolix

Intervention Type: DRUG

Provided as tablets for oral administration

Placebo to DMPA-SC

Intervention Type: DRUG

Matching placebo for subcutaneous injection in a pre-filled syringe

DMPA-SC

Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.

Group Type: ACTIVE_COMPARATOR

Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)

Intervention Type: DRUG

Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.

Placebo to Elagolix

Intervention Type: DRUG

Matching placebo tablets for oral administration

Interventions

Elagolix

Provided as tablets for oral administration

Intervention Type: DRUG

Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)

Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.

Intervention Type: DRUG

Placebo to Elagolix

Matching placebo tablets for oral administration

Intervention Type: DRUG

Placebo to DMPA-SC

Matching placebo for subcutaneous injection in a pre-filled syringe

Intervention Type: DRUG

Other Intervention Names

NBI-56418; Orilissa™; depo-subQ provera 104™

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

NBI-56418-0603

Identifier Type: -

Identifier Source: org_study_id