Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

NCT00437658 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NBI-56418-0603
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24

  Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.

  Baseline and week 24

• Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24

  Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.

  Baseline and week 24

Secondary Outcomes (27)

• Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48

  Baseline and weeks 12 and 48

• Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48

  Baseline and weeks 12 and 48

• Change From Baseline in N-telopeptide at Weeks 12, 24 and 48

  Baseline and weeks 12, 24 and 48

• Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24

  Baseline and week 24

• Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24

  Baseline and week 24

Study Arms (3)

Elagolix 75 mg BID

EXPERIMENTAL

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.

Drug: Elagolix; Drug: Placebo to DMPA-SC

Elagolix 150 mg QD

EXPERIMENTAL

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.

Drug: Elagolix; Drug: Placebo to DMPA-SC

DMPA-SC

ACTIVE COMPARATOR

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.

Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC); Drug: Placebo to Elagolix

Interventions

Elagolix DRUG

Provided as tablets for oral administration

Also known as: NBI-56418, Orilissa™

Elagolix 150 mg QD; Elagolix 75 mg BID

Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) DRUG

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

Also known as: depo-subQ provera 104™

DMPA-SC

Placebo to Elagolix DRUG

Matching placebo tablets for oral administration

DMPA-SC

Placebo to DMPA-SC DRUG

Matching placebo for subcutaneous injection in a pre-filled syringe

Elagolix 150 mg QD; Elagolix 75 mg BID

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Endometriosis

Interventions

elagolix; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 21, 2007
• Study Start: December 11, 2006
• Primary Completion: November 24, 2008
• Study Completion: November 24, 2008
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-03