Last updated on July 2013

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix (ABT-620), in Subjects with Moderate to Severe Endometriosis Associated Pain


Brief description of study

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix (ABT-620), in Subjects with Moderate to Severe Endometriosis Associated Pain

Detailed Study Description

Patient Inclusion Criteria:

  • Adult 18 to 49 years old premenopausal female with moderate to severe endometriosis-associated pain
  • Clinical diagnosis of endometriosis established by means of documented surgical visualization (laparoscopy or laparotomy) performed within 7 years of entry into the washout period or screening period.
  • Must agree to switch from her usual analgesic rescue medication to only those permitted by the protocol during the Washout Period, Screening, Treatment and Post-Treatment Follow-up Periods (through Month 6)
  • Must use two forms of non-hormonal contraception during the Washout Period if applicable, Screening Treatment and Post-treatment follow up periods through month 6 after month 3 in the post treatment follow up if preferable subjects may begin the use of hormonal contraception in place of non hormonal dual contraception.
  • Subject must have 2 normal menstrual cycles immediately prior to entering the Screening Period
  • Subject has a Composite Pelvic Signs and Symptoms Score total score of >6 at screening with a score of at least 2 for DYS AND at least 2 for NMPP.

Inclusion Criteria For Treatment Period

  • Subject must have at least two regular menstrual cycles within the Screening Period immediately prior to Day 1
  • At least 45 days of e-Diary entries during the Screening Period
  • At least 2 days of moderate or severe pain for DYS AND NMPP during the last 35 calendar days of the Screening Period prior to day 1
  • Subject must meet at least one of the following using the e-Diary entries:
    • Average NMPP during screening of at least 1.0 during the last 35 calendar days of the screening period or
    • At least 4 days of moderate or severe NMPP during the last 35 calendar days of the Screening Period
  • Subject has moderate to severe pain for DYS and NMPP using the Monthly Assessment of Endometeriosis
  • Pain on Day 1 (reflecting subject recall of the preceding menstrual month)
  • Subject has a Pap test collected during the Screening Period that contains adequate endocervical cells and shows no evidence of malignancy or pre-malignant changes
  • Subject >40 years of age has a normal mammogram within 1 year of randomization (subject with BI-RADS
  • Classification 1-3 is eligible for randomization)

Patient Exclusion Criteria:

  • Previous History of a severe, life threatening or other significant sensitivity to any drug
  • Subject is pregnant or breast feeding or is planning pregnancy within the next 24 months
  • Less than 6 months postpartum, post abortion or post pregnancy at the time of entry into the Screening Period
  • History of Drug (licit or illicit) or alcohol abuse within 1 year of Washout Period or screening.
  • Subject has a screening test result for Hepatitis A Virus Immunoglobulin M (HAV-IgM), Hepatitis B Surface Antigen, or Hepatitis C Virus Antibody, or HIV or Human Immunodeficiency Virus Antibody. The HIV /HIV Ab results will be maintained confidentially by the study site.
  • Subject has used any known inducers of cytochrome P450 3A within 1 month prior to screening
  • Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis including aspartate aminotransferase or alanine aminotransferase or bilirubin >1.5 timesw the upper limit of the reference range or a serum creatinine >1.5mg/dL at screening
  • Newly diagnosed or clinically significant medical conjdition that requires intervention or an unstble medical condigion that makes the subecg an unsuitable candidate for the studh in the opinion of the investigator
  • History of major depresion within 2 years of screening, or history of other major psychiatric disorder at any time.
  • Surgical history of: hysterectomy, bilatetal oophorectomy, surgical procedure that interferes with gastrointestinal motility, pH, or absorption, any major surgery.
  • History of previous non-response to GnRH agonists, GnRH antagonists, DMPA, or arinatase inhibitors as assessed by subject report of no improvement in DYS or NMPP
  • Subject has required more than 2 weeks of continuous use of a prohibited long-acting narcotic or immediate release narcotic for treatment of endometriosis-associated pain within 6 months of entry into the Washout Period if applicable or Screening Period.
  • Chronic Pelvic pain that is not caused by endometriosis

Clinical Study Identifier: TX13532

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Mrs. Morales

Miami Dade Medical Research Institute, LLC
Miami, FL USA
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