Overview

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Status:
Completed
Trial end date:
2008-11-24
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
AbbVie (prior sponsor, Abbott)
Treatments:
Medroxyprogesterone
Medroxyprogesterone Acetate
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