Elagolix for Endometriosis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Yale University
Disqualifiers: Smoking, Diabetes, Sleep apnea, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Elagolix for treating endometriosis?
Research shows that Elagolix significantly reduces pain associated with endometriosis, including menstrual and non-menstrual pelvic pain, and helps decrease fatigue in women with moderate to severe endometriosis-related pain.
12345Is Elagolix safe for humans?
Elagolix has been approved by the U.S. FDA for managing pain associated with endometriosis, and studies have evaluated its safety over 12 months. It is generally considered safe, but like any medication, it may have side effects, which healthcare providers can discuss with you.
12356How is the drug Elagolix unique for treating endometriosis?
Elagolix is unique because it is an oral medication that works by blocking gonadotropin-releasing hormone (GnRH) receptors, which reduces hormone levels like estrogen and progesterone, helping to decrease inflammation and the growth of endometrial tissue, thus relieving pain associated with endometriosis.
24678Eligibility Criteria
This trial is for young women aged 18-45, both healthy and those with endometriosis. It's not open to women who have diabetes, severe acute pain from endometriosis needing immediate treatment, high blood pressure (BP>140/90), sleep apnea, or those who smoke.Inclusion Criteria
I am a woman aged between 18 and 45.
I am a woman aged 18-45 with endometriosis.
Exclusion Criteria
You are a smoker.
I have diabetes.
I do not have severe acute pain from endometriosis needing immediate treatment.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive estrogen suppression treatment to assess its impact on endothelial dysfunction and cardiovascular risk
8-12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing Elagolix to see if reducing estrogen levels affects the health of blood vessels in women with endometriosis. The idea is that less estrogen might lead to worse vessel function.
2Treatment groups
Experimental Treatment
Active Control
Group I: patients with endometriosisExperimental Treatment1 Intervention
Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor.
Group II: patients without endometriosisActive Control1 Intervention
Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis
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:
Yale School of MedicineNew Haven, CT
John B Pierce LaboratoryNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis. [2019]To evaluate the efficacy of elagolix, an oral GnRH antagonist, for the reduction of fatigue in women with moderate or severe endometriosis-associated pain.
Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. [2022]Elagolix is an orally active, gonadotropin-releasing hormone receptor antagonist approved for the management of endometriosis-associated pain and heavy menstrual bleeding associated with uterine fibroids. Elagolix population pharmacokinetics and factors affecting elagolix exposure in healthy women and women with endometriosis have been reported previously. The purpose of this study was to extend the population pharmacokinetics model with additional modifications to incorporate data from phase III studies of elagolix with hormonal add-back therapy in women with uterine fibroids.
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.
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.
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.
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 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.
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.