A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-I)

September 14, 2018 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
872

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Washout (if applicable) or Screening.
  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 menstrual cycles 24 to 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 (subject report of partial response to or side effects from these agents is not exclusionary).
  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 genital bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Elagolix 150 mg QD
Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
Drug: elagolix
oral tablet
Other Names:
  • ABT-620, elagolix sodium
EXPERIMENTAL: Elagolix 200 mg BID
Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
Drug: elagolix
oral tablet
Other Names:
  • ABT-620, elagolix sodium
PLACEBO_COMPARATOR: Placebo
Placebo BID for the 6-month Treatment Period
Other: placebo
oral tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
Time Frame: At Month 3 of the Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 3 of the Treatment Period
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
Time Frame: At Month 3 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 3 of Treatment Period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
Time Frame: Baseline, Month 3 of the Treatment Period
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Baseline, Month 3 of the Treatment Period
Change From Baseline to Month 6 in DYS
Time Frame: Baseline, Month 6 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 6 in NMPP
Time Frame: Baseline, Month 6 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 3 in Dyspareunia (DYSP)
Time Frame: Baseline, Month 3 of Treatment Period
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Time Frame: Baseline, Month 3 of Treatment Period
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Time Frame: Baseline, Month 6 of Treatment Period
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Time Frame: Baseline, Month 3 of Treatment Period
Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 3 of Treatment Period
Percentage of Responders at Month 1 Based on Daily Assessment of DYS
Time Frame: At Month 1 of the Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 1 of the Treatment Period
Percentage of Responders at Month 2 Based on Daily Assessment of DYS
Time Frame: At Month 2 of the Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 2 of the Treatment Period
Percentage of Responders at Month 4 Based on Daily Assessment of DYS
Time Frame: At Month 4 of the Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 4 of the Treatment Period
Percentage of Responders at Month 5 Based on Daily Assessment of DYS
Time Frame: At Month 5 of the Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 5 of the Treatment Period
Percentage of Responders at Month 6 Based on Daily Assessment of DYS
Time Frame: At Month 6 of the Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 6 of the Treatment Period
Percentage of Responders at Month 1 Based on Daily Assessment of NMPP
Time Frame: At Month 1 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 1 of Treatment Period
Percentage of Responders at Month 2 Based on Daily Assessment of NMPP
Time Frame: At Month 2 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 2 of Treatment Period
Percentage of Responders at Month 4 Based on Daily Assessment of NMPP
Time Frame: At Month 4 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 4 of Treatment Period
Percentage of Responders at Month 5 Based on Daily Assessment of NMPP
Time Frame: At Month 5 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 5 of Treatment Period
Percentage of Responders at Month 6 Based on Daily Assessment of NMPP
Time Frame: At Month 6 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 6 of Treatment Period
Percentage of Responders at Month 1 for DYSP
Time Frame: At Month 1 of the Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 1 of the Treatment Period
Percentage of Responders at Month 2 for DYSP
Time Frame: At Month 2 of the Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 2 of the Treatment Period
Percentage of Responders at Month 4 for DYSP
Time Frame: At Month 4 of the Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 4 of the Treatment Period
Percentage of Responders at Month 5 for DYSP
Time Frame: At Month 5 of the Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 5 of the Treatment Period
Percentage of Responders at Month 6 for DYSP
Time Frame: At Month 6 of the Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
At Month 6 of the Treatment Period
Change From Baseline to Month 1 in Mean Pain Score for DYS
Time Frame: Baseline, Month 1 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in Mean Pain Score for DYS
Time Frame: Baseline, Month 2 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in Mean Pain Score for DYS
Time Frame: Baseline, Month 3 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in Mean Pain Score for DYS
Time Frame: Baseline, Month 4 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in Mean Pain Score for DYS
Time Frame: Baseline, Month 5 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 5 of Treatment Period
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
Time Frame: Baseline, Month 1 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 1 of Treatment Period
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
Time Frame: Baseline, Month 2 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 2 of Treatment Period
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
Time Frame: Baseline, Month 3 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 3 of Treatment Period
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
Time Frame: Baseline, Month 4 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 4 of Treatment Period
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
Time Frame: Baseline, Month 5 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 5 of Treatment Period
Percent Change From Baseline to Month 6 in Mean Pain Score for DYS
Time Frame: Baseline, Month 6 of Treatment Period
The DYS pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 1 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 2 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 3 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 4 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 5 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 5 of Treatment Period
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 1 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 1 of Treatment Period
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 2 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 2 of Treatment Period
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 3 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 3 of Treatment Period
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 4 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 4 of Treatment Period
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 5 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 5 of Treatment Period
Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP
Time Frame: Baseline, Month 6 of Treatment Period
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in Mean Pain Score of DYSP
Time Frame: Baseline, Month 1 of Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in Mean Pain Score of DYSP
Time Frame: Baseline, Month 2 of Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 4 in Mean Pain Score of DYSP
Time Frame: Baseline, Month 4 of Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in Mean Pain Score of DYSP
Time Frame: Baseline, Month 5 of Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in Mean Pain Score of DYSP
Time Frame: Baseline, Month 6 of Treatment Period
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics
Time Frame: Baseline, Month 1 of Treatment Period
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics
Time Frame: Baseline, Month 2 of Treatment Period
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics
Time Frame: Baseline, Month 4 of Treatment Period
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics
Time Frame: Baseline, Month 5 of Treatment Period
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Baseline, Month 5 of Treatment Period
Response to Patient Global Impression of Change (PGIC) at Month 1
Time Frame: Month 1 of Treatment Period
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Month 1 of Treatment Period
Response to PGIC at Month 2
Time Frame: Month 2 of Treatment Period
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Month 2 of Treatment Period
Response to PGIC at Month 3
Time Frame: Month 3 of Treatment Period
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Month 3 of Treatment Period
Response to PGIC at Month 4
Time Frame: Month 4 of Treatment Period
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Month 4 of Treatment Period
Response to PGIC at Month 5
Time Frame: Month 5 of Treatment Period
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Month 5 of Treatment Period
Response to PGIC at Month 6
Time Frame: Month 6 of Treatment Period
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Month 6 of Treatment Period
Change From Baseline to Month 1 in NRS Scores
Time Frame: Baseline, Month 1 of Treatment Period
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in NRS Scores
Time Frame: Baseline, Month 2 of Treatment Period
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 4 in NRS Scores
Time Frame: Baseline, Month 4 of Treatment Period
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in NRS Scores
Time Frame: Baseline, Month 5 of Treatment Period
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in NRS Scores
Time Frame: Baseline, Month 6 of Treatment Period
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)
Time Frame: Baseline, Month 1 of Treatment Period
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 3 in the Pain Domain of the EHP-30
Time Frame: Baseline, Month 3 of Treatment Period
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 6 in the Pain Domain of the EHP-30
Time Frame: Baseline, Month 6 of Treatment Period
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30
Time Frame: Baseline, Month 1 of Treatment Period
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30
Time Frame: Baseline, Month 3 of Treatment Period
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30
Time Frame: Baseline, Month 6 of Treatment Period
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
Time Frame: Baseline, Month 1 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Time Frame: Baseline, Month 2 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Time Frame: Baseline, Month 3 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Time Frame: Baseline, Month 4 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Time Frame: Baseline, Month 5 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Time Frame: Baseline, Month 6 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Time Frame: Baseline, Month 1 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Time Frame: Baseline, Month 2 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Time Frame: Baseline, Month 3 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Time Frame: Baseline, Month 4 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Time Frame: Baseline, Month 5 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Time Frame: Baseline, Month 6 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Time Frame: Baseline, Month 1 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Time Frame: Baseline, Month 2 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Time Frame: Baseline, Month 3 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Time Frame: Baseline, Month 4 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Time Frame: Baseline, Month 5 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Time Frame: Baseline, Month 6 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Time Frame: Baseline, Month 1 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Time Frame: Baseline, Month 2 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Time Frame: Baseline, Month 3 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Time Frame: Baseline, Month 4 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Time Frame: Baseline, Month 5 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Time Frame: Baseline, Month 6 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Time Frame: Baseline, Month 1 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Time Frame: Baseline, Month 2 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Time Frame: Baseline, Month 3 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Time Frame: Baseline, Month 4 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Time Frame: Baseline, Month 5 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Time Frame: Baseline, Month 6 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 6 of Treatment Period
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Time Frame: Baseline, Month 1 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 1 of Treatment Period
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Time Frame: Baseline, Month 2 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 2 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Time Frame: Baseline, Month 3 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 3 of Treatment Period
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Time Frame: Baseline, Month 4 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 4 of Treatment Period
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Time Frame: Baseline, Month 5 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 5 of Treatment Period
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Time Frame: Baseline, Month 6 of Treatment Period
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Baseline, Month 6 of Treatment Period
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Time Frame: Up to Month 6 of Treatment Period
Up to Month 6 of Treatment Period
Number of Days of Hospitalization
Time Frame: Up to Month 6 of Treatment Period
Up to Month 6 of Treatment Period
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Time Frame: Up to Month 6 of Treatment Period
Up to Month 6 of Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M12-665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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