Elagolix + COC for Endometriosis
(ELARIS EM-COC Trial)
Recruiting in Palo Alto (17 mi)
+107 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
Must be taking: Combined oral contraceptives
Disqualifiers: Pregnancy, Hysterectomy, Osteoporosis, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.
Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.
Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.
There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you must agree to use non-hormonal contraception during certain periods of the study, which might affect your current medication use.
What data supports the effectiveness of the drug Elagolix for treating endometriosis?
Elagolix has been shown to significantly reduce pain associated with endometriosis, including menstrual pain and non-menstrual pelvic pain, and improve quality of life for women with this condition. It works by lowering hormone levels that contribute to the growth of endometrial tissue outside the uterus.
12345What makes the drug Elagolix unique for treating endometriosis?
Elagolix is unique because it is an oral medication that works by blocking certain hormone receptors, reducing levels of hormones like estrogen and progesterone, which helps decrease inflammation and the growth of endometrial tissue. This mechanism is different from other treatments that may not target hormone suppression directly.
12567Eligibility Criteria
This trial is for adult women who have endometriosis with moderate to severe pain and are suitable candidates for combined oral contraceptives (COCs). They must not be pregnant, breastfeeding, or planning pregnancy until the study ends. Participants should not have had a hysterectomy or oophorectomy, osteoporosis, other metabolic bone diseases, or any chronic pain conditions that could affect their pain assessment.Inclusion Criteria
Documented surgical confirmation of endometriosis and associated moderate to severe pain.
Have you been surgically diagnosed with Endometriosis and have documentation?
Are your menstrual cycles regular, meaning every 21-35 days?
+2 more
Exclusion Criteria
Are you currently breastfeeding, pregnant, or planning a pregnancy.
You have been diagnosed with PCOS
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Double-Blind Treatment
Participants receive double-blind elagolix or placebo in combination with COC for 3 months
3 months
Regular visits at a hospital or clinic
Open-Label Treatment
All participants receive open-label elagolix in combination with COC for 15 months
15 months
Regular visits at a hospital or clinic
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Participant Groups
The study tests how well elagolix works with COCs compared to a placebo in managing painful periods due to endometriosis. About 800 participants will be randomly assigned to one of three groups: two receiving different treatments and one receiving a placebo. After three months on varied regimens, all participants will receive elagolix with COCs from Month 4 through Month 18.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-Blind: Elagolix + COCExperimental Treatment2 Interventions
Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.
Group II: Double-Blind: ElagolixExperimental Treatment2 Interventions
Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Group III: Double-Blind: PlaceboPlacebo Group3 Interventions
Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Elagolix is already approved in United States for the following indications:
🇺🇸 Approved in United States as Orilissa for:
- Management of moderate to severe pain associated with endometriosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern Medicine Fertility and Reproductive Medicine /ID# 244255Chicago, IL
Advances in Health, Inc. /ID# 217220Houston, TX
GTC Research /ID# 217051Kansas City, KS
Revive Research Institute - Dearborn Heights /ID# 248500Dearborn Heights, MI
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Elagolix as a Novel Treatment for Endometriosis-Related Pain. [2020]Endometriosis, which is the growth of endometrial tissue outside of the uterus, is estimated to affect up to 10% of reproductive-age women. Symptoms associated with endometriosis include dysmenorrhea, chronic pelvic pain, and dyspareunia. In July 2018, the U.S. Food and Drug Administration approved elagolix (Orilissa, AbbVie, North Chicago, IL) as an oral treatment for endometriosis-related pain. This medication is a gonadotropin-releasing hormone receptor antagonist that works by suppressing levels of hormones, including estrogen and progesterone. This helps decrease inflammation and the proliferation of endometrial tissue. In this column, I provide an overview of elagolix and discuss contraindications, adverse effects, and practice implications for nurses who work with women affected by endometriosis.
Elagolix: First Global Approval. [2019]Elagolix (ORILISSA™), an orally bioavailable, second-generation, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, is being developed AbbVie and Neurocrine Biosciences for the treatment of reproductive hormone-dependent disorders in women. In July 2018, the US FDA approved elagolix tablets for the management of moderate to severe pain associated with endometriosis. This approval was based on positive results in two replicate phase III trials; additional phase III trials in the USA, Canada and Puerto Rico are currently evaluating elagolix as both monotherapy and in combination with low-dose hormone add-back therapy in the same indication. Elagolix with and without low-dose hormone add-back therapy is also undergoing phase III clinical development for heavy menstrual bleeding associated with uterine fibroids in the aforementioned locations. This article summarizes the milestones in the development of elagolix leading to its first approval for the management of moderate to severe pain associated with endometriosis.
Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. [2019]To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain.
Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. [2022]To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30).
Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. [2022]Elagolix is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist, that significantly reduces dysmenorrhea and non-menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis-associated pain.
LC-MS-Compatible Chromatographic Method for Quantification of Potential Organic Impurities of Elagolix Sodium in Tablet Dosage Form with Identification of Major Degradation Products. [2023]Elagolix is a gonadotropin-releasing hormone (GnRH) modulator and used for pain relief from endometriosis.
Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. [2020]Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist recently approved for the treatment of endometriosis-associated pain and being developed for heavy menstrual bleeding associated with uterine fibroids.