Efficacy and Safety Study of Elagolix in Women With Endometriosis

NCT00973973 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NBI-56418-0901
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Conditions

Endometriosis, Pain

Keywords

Pelvic Pain,NBI-56418,Endometriosis

Outcome Measures

Primary Outcomes (8)

• Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase

  Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an electronic diary (e-Diary) according to the following response options: * 0 = No discomfort * 1 = Mild discomfort but I was easily able to do the things I usually do * 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3 = Severe pain that made it difficult to do the things I usually do. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit.

  Baseline and Weeks 4 and 8

• Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases

  Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an electronic diary (e-Diary) according to the following response options: * 0 = No discomfort * 1 = Mild discomfort but I was easily able to do the things I usually do * 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3 = Severe pain that made it difficult to do the things I usually do. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data.

  Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

• Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase

  Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having their period in an e-Diary according to the following response options: * 0 = No discomfort * 1 = Mild discomfort but I was easily able to do the things I usually do * 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3 = Severe pain that made it difficult to do the things I usually do. The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit.

  Baseline and weeks 4 and 8

• Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases

  Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having their period in an e-Diary according to the following response options: * 0 = No discomfort * 1 = Mild discomfort but I was easily able to do the things I usually do * 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3 = Severe pain that made it difficult to do the things I usually do. The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data.

  Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

• Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase

  Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following: * 0 = No discomfort * 1 = Mild discomfort but I was easily able to do the things I usually do * 2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3 = Severe pain that made it difficult to do the things I usually do. The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit.

  Baseline and weeks 4 and 8

• Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases

  Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following: * 0: No discomfort * 1: Mild discomfort, I was easily able to do the things I usually do * 2: Moderate discomfort or pain making it difficult to do some of the things I usually do * 3: Severe pain making it difficult to do the things I usually do The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data.

  Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

• Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase

  Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options: * 0 = Absent; No discomfort during sexual intercourse * 1 = Mild; I was able to tolerate the discomfort during sexual intercourse * 2 = Moderate; Intercourse was interrupted due to pain * 3 = Severe; I avoided intercourse because of pain * Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit. Responses of "does not apply" were not included in the calculations.

  Baseline and weeks 4 and 8

• Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases

  Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options: * 0: Absent; No discomfort during sexual intercourse * 1: Mild; I was able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; I avoided intercourse because of pain * Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit, except for week 30 which is based on 6 weeks of data. Responses of "does not apply" were not included in the calculations.

  Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)

Secondary Outcomes (20)

• Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8

  Baseline and Week 8

• Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8

  Baseline and Week 8

• Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8

  Baseline and Week 8

• Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8

  Baseline and Week 8

• Change From Baseline in the Percentage of Days of Any Analgesic Use During the Double-Blind Treatment Phase

  Baseline and Weeks 4 and 8

Study Arms (2)

Elagolix 150 mg

EXPERIMENTAL

Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.

Drug: Elagolix

Placebo

PLACEBO COMPARATOR

Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.

Drug: Placebo; Drug: Elagolix

Interventions

Placebo DRUG

Matching placebo tablets taken orally once a day

Placebo

Elagolix DRUG

Immediate release (IR) tablets taken orally once a day

Also known as: NBI-56418, Orilissa™

Elagolix 150 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be female, aged 18 to 49 years, inclusive.
• Have moderate to severe pelvic pain due to endometriosis.
• Have a history of regular menstrual cycles.
• Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening.
• Have a Body Mass Index (BMI) of 18 to 36 kg/m², inclusive.
• Agree to use two forms of non-hormonal contraception during the study.

You may not qualify if:

• Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist other than NBI-56418, or danazol or have received any of these agents within 6 months of the start of screening.
• Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
• Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.
• Have had surgery for endometriosis within the last month.
• Have had a hysterectomy or bilateral oophorectomy.
• Are using systemic steroids on a chronic or regular basis within 3 months.
• Have uterine fibroids ≥ 3 cm in diameter.
• Have pelvic pain that is not caused by endometriosis.
• Have unstable medical condition or chronic disease.
• Have been pregnant within the last six months.
• Currently breast feeding.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Endometriosis; Pain

Interventions

elagolix

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2009
• First Posted: September 9, 2009
• Study Start: October 12, 2009
• Primary Completion: September 22, 2010
• Study Completion: September 22, 2010
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-04