Overview
Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis
Status:
Completed
Completed
Trial end date:
2008-11-24
2008-11-24
Target enrollment:
0
0
Participant gender:
Female
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 2Accepts Healthy Volunteers?
NoDetails
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