- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620528
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
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
Interventional
Enrollment (Actual)
872
Phase
- 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
Ages Eligible for Study
18 years to 49 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
- Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
- Agrees to use required birth control methods during the entire length of participation in the study.
- 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:
- 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.
- 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).
- 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.
- Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
- Subject has a history of osteoporosis or other metabolic bone disease.
- 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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Elagolix 150 mg QD
Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
|
oral tablet
Other Names:
|
EXPERIMENTAL: Elagolix 200 mg BID
Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
|
oral tablet
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Placebo BID for the 6-month Treatment Period
|
oral tablet
|
What is the study measuring?
Primary Outcome Measures
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
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
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
- Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.
- Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8. Erratum In: Clin Transl Sci. 2022 Mar;15(3):799.
- Stodtmann S, Nader A, Polepally AR, Suleiman AA, Winzenborg I, Noertersheuser P, Ng J, Mostafa NM, Shebley M. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis. Clin Transl Sci. 2021 Jul;14(4):1611-1619. doi: 10.1111/cts.13040. Epub 2021 May 7.
- Abbas Suleiman A, Nader A, Winzenborg I, Beck D, Polepally AR, Ng J, Noertersheuser P, Mostafa NM. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain. CPT Pharmacometrics Syst Pharmacol. 2020 Nov;9(11):639-648. doi: 10.1002/psp4.12560. Epub 2020 Oct 8.
- Winzenborg I, Polepally AR, Nader A, Mostafa NM, Noertersheuser P, Ng J. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model. CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):466-475. doi: 10.1002/psp4.12545. Epub 2020 Jul 31.
- Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.
- Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.
- Abrao MS, Surrey E, Gordon K, Snabes MC, Wang H, Ijacu H, Taylor HS. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021 Jun 16;21(1):246. doi: 10.1186/s12905-021-01385-3.
- Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021.
- Pokrzywinski RM, Soliman AM, Snabes MC, Chen J, Taylor HS, Coyne KS. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis. Fertil Steril. 2021 Feb;115(2):423-430. doi: 10.1016/j.fertnstert.2020.07.013. Epub 2020 Oct 14.
- Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917.
- Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7.
- Pokrzywinski RM, Soliman AM, Chen J, Snabes M, Diamond MP, Surrey E, Coyne KS. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials. Fertil Steril. 2019 Sep;112(3):545-551. doi: 10.1016/j.fertnstert.2019.04.031. Epub 2019 Jun 18. Erratum In: Fertil Steril. 2020 Jan;113(1):237.
- Surrey ES, Soliman AM, Agarwal SK, Snabes MC, Diamond MP. Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis. Fertil Steril. 2019 Aug;112(2):298-304.e3. doi: 10.1016/j.fertnstert.2019.02.031. Epub 2019 Apr 13.
- Wang ST, Johnson SJ, Mitchell D, Soliman AM, Vora JB, Agarwal SK. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA. J Comp Eff Res. 2019 Apr;8(5):337-355. doi: 10.2217/cer-2018-0124. Epub 2019 Feb 6.
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
May 22, 2012
Primary Completion (ACTUAL)
November 14, 2014
Study Completion (ACTUAL)
September 28, 2015
Study Registration Dates
First Submitted
May 15, 2012
First Submitted That Met QC Criteria
June 13, 2012
First Posted (ESTIMATE)
June 15, 2012
Study Record Updates
Last Update Posted (ACTUAL)
September 18, 2018
Last Update Submitted That Met QC Criteria
September 14, 2018
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Endometriosis
-
Fabio BarraCompletedEndometriosis | Endometriosis, Rectum | Endometriosis of Vagina | Endometriosis Rectovaginal Septum | Endometriosis Pelvic | Endometriosis of ColonItaly
-
Ospedale Policlinico San MartinoCompletedEndometriosis | Bowel Endometriosis | Endometriosis, Rectum | Endometriosis ColonItaly
-
BioGene Pharmaceutical Ltd.WithdrawnSafety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis (ELTA)Endometriosis | Endometriosis Ovary | Endometriosis, Rectum | Endometriosis ExternaSwitzerland
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...CompletedEndometriosis | Endometriosis-related Pain | Endometriosis Thoracic | Endometriosis of Lung | Endometriosis of PleuraItaly
-
Ospedale Policlinico San MartinoCompletedEndometriosis, Rectum | Endometriosis, SigmoidItaly
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknownBowel Endometriosis | Endometriosis, RectumItaly
-
Ospedale Policlinico San MartinoActive, not recruitingEndometriosis, Rectum | Endometriosis of ColonItaly
-
Catholic University of the Sacred HeartCompletedPelvic Endometriosis | Endometriosis Outside PelvisItaly
-
Semmelweis UniversityUniversity of PecsNot yet recruitingEndometriosis | Endometriosis Ovary | Endometriosis Rectovaginal Septum
-
Catholic University of the Sacred HeartCompletedPelvic Endometriosis | Endometriosis Outside PelvisItaly
Clinical Trials on elagolix
-
AbbVie (prior sponsor, Abbott)Neurocrine BiosciencesCompletedFolliculogenesisUnited States, Puerto Rico
-
Nanjing Chia-tai Tianqing PharmaceuticalRecruiting
-
Qilu Pharmaceutical (Hainan) Co., Ltd.Recruiting
-
AbbVieCompletedUterine FibroidsUnited States, Puerto Rico
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
BayerTerminatedEndometriosisSpain, Belgium, United States, Germany, Austria, Japan, Canada, Hungary, Bulgaria, Italy, China, Czechia, Finland, Norway, Poland, Slovakia, Estonia, Greece, Latvia, Lithuania
-
AbbVieActive, not recruitingUterine Fibroids | Heavy Menstrual BleedingUnited States, Puerto Rico
-
AbbVieCompletedEndometriosis, Pain
-
AbbVieCompletedPolycystic Ovary SyndromeUnited States, Puerto Rico