A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01931670
First received: August 27, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.


Condition Intervention Phase
Endometriosis
Drug: Elagolix
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of responders with Endometriosis Associated Pain assessed using modified Biberoglu and Behrman (B&B) scale [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    Proportion of responders based on reduction from Baseline

  • Change in Bone Mineral Density as assessed by the Dual-energy X-Ray Absorptiometry (DXA) Scan [ Time Frame: From Month 0 to Month 18 ] [ Designated as safety issue: Yes ]
    Change from Baseline in Bone Mineral Density

  • Change in Endometrial Thickness assessed by Transvaginal Ultrasound (TVU) [ Time Frame: From Month 0 to Month 6 ] [ Designated as safety issue: Yes ]
    Change from Baseline in endometrial thickness

  • Change in percentage of subjects with significant Transvaginal Ultrasound (TVU) findings [ Time Frame: From Month 0 to Month 6 ] [ Designated as safety issue: Yes ]
    Percent of subjects with ovarian cyst


Secondary Outcome Measures:
  • Change in Clinical Laboratory Tests [ Time Frame: From Month 0 to Month 9 ] [ Designated as safety issue: Yes ]
    Mean change from Baseline (hematology, chemistry, urinalysis and endocrine testing)

  • Proportion of subjects with Adverse Events [ Time Frame: Up to Month 18 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 788
Study Start Date: September 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elagolix Dose 1
6 Month Treatment Period
Drug: Elagolix
Elagolix Dose 1 for 6 month Treatment Period, Elagolix Dose 2 for the 6 month Treatment Period
Other Name: ABT-620, elagolix sodium
Experimental: Elagolix Dose 2
6 Month Treatment Period
Drug: Elagolix
Elagolix Dose 1 for 6 month Treatment Period, Elagolix Dose 2 for the 6 month Treatment Period
Other Name: ABT-620, elagolix sodium
Placebo Comparator: Placebo
6 Month Treatment with matching Placebo
Other: placebo
Placebo for 6 Month Treatment Period

Detailed Description:

The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
  2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
  3. Agrees to use required birth control methods during the entire length of participation in the study.
  4. Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
  5. Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.

Exclusion Criteria:

  1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
  2. Subject has a history of previous non-response to gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain.
  3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
  4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
  5. Subject has a history of osteoporosis or other metabolic bone disease.
  6. Subject has a current history of undiagnosed abnormal uterine bleeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931670

Contacts
Contact: Cynthia Mattia-Goldberg, MS 847-938-1460 cynthia.mattia-goldberg@abbvie.com
Contact: Heather Gibbs, BS 847-937-2763 heather.gibbs@abbvie.com

  Show 251 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Jean Rowan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01931670     History of Changes
Other Study ID Numbers: M12-671, 2011-004295-11
Study First Received: August 27, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration
Australia: National Health and Medical Research Council
South Africa: Department of Health
Italy: National Institute of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Ministry of Health and Consumption
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
Austria: Austrian Medicines and Medical Devices Agency
Hungary: Ministry of Health, Social and Family Affairs
New Zealand: Medsafe

Keywords provided by AbbVie:
Endometriosis Associated Pain
Dysmenorrhea (DYS)
Elagolix
Gonadotropin-Releasing Hormone Antagonist
Non-Menstrual Pelvic Pain (NMPP)

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 23, 2014