Brief Summary
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.
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
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.
Completion Date
Completion Date Type
Actual
Conditions
Endometriosis
Eligibility 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 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.
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.
Inclusion 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 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
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
Gender
Female
Gender Based
false
Keywords
Gonadotropin-Releasing Hormone Antagonist
Endometriosis associated pain
Dysmenorrhea (DYS)
Non-Menstrual Pelvic Pain (NMPP)
Elagolix
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
49 Years
Minimum Age
18 Years
NCT Id
NCT01620528
Org Class
Industry
Org Full Name
AbbVie
Org Study Id
M12-665
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
Outcome Time Frame
At Month 3 of the Treatment Period
Outcome Description
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.
Outcome Measure
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
Outcome Time Frame
At Month 3 of Treatment Period
Secondary Outcomes
Outcome Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Outcome Time Frame
Baseline, Month 3 of the Treatment Period
Outcome Measure
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in DYS
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in NMPP
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Outcome Description
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in Dyspareunia (DYSP)
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Outcome Description
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.
Outcome Time Frame
At Month 1 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 1 Based on Daily Assessment of DYS
Outcome Description
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.
Outcome Time Frame
At Month 2 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 2 Based on Daily Assessment of DYS
Outcome Description
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.
Outcome Time Frame
At Month 4 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 4 Based on Daily Assessment of DYS
Outcome Description
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.
Outcome Time Frame
At Month 5 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 5 Based on Daily Assessment of DYS
Outcome Description
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.
Outcome Time Frame
At Month 6 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 6 Based on Daily Assessment of DYS
Outcome Description
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.
Outcome Time Frame
At Month 1 of Treatment Period
Outcome Measure
Percentage of Responders at Month 1 Based on Daily Assessment of NMPP
Outcome Description
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.
Outcome Time Frame
At Month 2 of Treatment Period
Outcome Measure
Percentage of Responders at Month 2 Based on Daily Assessment of NMPP
Outcome Description
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.
Outcome Time Frame
At Month 4 of Treatment Period
Outcome Measure
Percentage of Responders at Month 4 Based on Daily Assessment of NMPP
Outcome Description
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.
Outcome Time Frame
At Month 5 of Treatment Period
Outcome Measure
Percentage of Responders at Month 5 Based on Daily Assessment of NMPP
Outcome Description
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.
Outcome Time Frame
At Month 6 of Treatment Period
Outcome Measure
Percentage of Responders at Month 6 Based on Daily Assessment of NMPP
Outcome Description
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.
Outcome Time Frame
At Month 1 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 1 for DYSP
Outcome Description
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.
Outcome Time Frame
At Month 2 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 2 for DYSP
Outcome Description
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.
Outcome Time Frame
At Month 4 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 4 for DYSP
Outcome Description
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.
Outcome Time Frame
At Month 5 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 5 for DYSP
Outcome Description
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.
Outcome Time Frame
At Month 6 of the Treatment Period
Outcome Measure
Percentage of Responders at Month 6 for DYSP
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
Outcome Description
The DYS pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 6 in Mean Pain Score for DYS
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP
Outcome Description
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP
Outcome Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in Mean Pain Score of DYSP
Outcome Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in Mean Pain Score of DYSP
Outcome Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in Mean Pain Score of DYSP
Outcome Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in Mean Pain Score of DYSP
Outcome Description
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in Mean Pain Score of DYSP
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics
Outcome Description
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.
Outcome Time Frame
Month 1 of Treatment Period
Outcome Measure
Response to Patient Global Impression of Change (PGIC) at Month 1
Outcome Description
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.
Outcome Time Frame
Month 2 of Treatment Period
Outcome Measure
Response to PGIC at Month 2
Outcome Description
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.
Outcome Time Frame
Month 3 of Treatment Period
Outcome Measure
Response to PGIC at Month 3
Outcome Description
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.
Outcome Time Frame
Month 4 of Treatment Period
Outcome Measure
Response to PGIC at Month 4
Outcome Description
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.
Outcome Time Frame
Month 5 of Treatment Period
Outcome Measure
Response to PGIC at Month 5
Outcome Description
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.
Outcome Time Frame
Month 6 of Treatment Period
Outcome Measure
Response to PGIC at Month 6
Outcome Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in NRS Scores
Outcome Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in NRS Scores
Outcome Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in NRS Scores
Outcome Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in NRS Scores
Outcome Description
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in NRS Scores
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in the Pain Domain of the EHP-30
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in the Pain Domain of the EHP-30
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Outcome Description
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.
Outcome Time Frame
Baseline, Month 1 of Treatment Period
Outcome Measure
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Outcome Description
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.
Outcome Time Frame
Baseline, Month 2 of Treatment Period
Outcome Measure
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Outcome Description
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.
Outcome Time Frame
Baseline, Month 3 of Treatment Period
Outcome Measure
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Outcome Description
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.
Outcome Time Frame
Baseline, Month 4 of Treatment Period
Outcome Measure
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Outcome Description
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.
Outcome Time Frame
Baseline, Month 5 of Treatment Period
Outcome Measure
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Outcome Description
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.
Outcome Time Frame
Baseline, Month 6 of Treatment Period
Outcome Measure
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Outcome Time Frame
Up to Month 6 of Treatment Period
Outcome Measure
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Outcome Time Frame
Up to Month 6 of Treatment Period
Outcome Measure
Number of Days of Hospitalization
Outcome Time Frame
Up to Month 6 of Treatment Period
Outcome Measure
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
49
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Scott Chudnoff
Investigator Email
schudnof@montefiore.org
Investigator Phone