Orilissa

Endometriosis, Menorrhagia, Uterine Fibroids + 1 more

Treatment

20 Active Studies for Orilissa

What is Orilissa

Elagolix

The Generic name of this drug

Treatment Summary

Elagolix (brand name Orilissa) is a medication used to treat moderate to severe pain caused by endometriosis. It is the first and only oral medication specifically developed for women with endometriosis pain. Endometriosis is a common gynecologic disorder that can cause women to suffer from debilitating pain for up to ten years before receiving a proper diagnosis. Orilissa was approved by the FDA under priority review, allowing healthcare professionals to provide women with another option for treating their endometriosis symptoms.

Orilissa

is the brand name

image of different drug pills on a surface

Orilissa Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Orilissa

Elagolix

2018

3

Effectiveness

How Orilissa Affects Patients

In a study with healthy women, the elagolix 150 mg once daily regimen and the 200 mg twice daily regimen resulted in a 50% and 32% ovulation rate, respectively. In trials with women with endometriosis, it was seen that these doses caused a reduction in estradiol concentrations to around 42 pg/mL and 12 pg/mL respectively. Additionally, a single dose of 1200 mg was investigated in a study with 48 premenopausal women, and it was found that this dose did not cause any prolonged effects on the QTc interval.

How Orilissa works in the body

Endometriosis is a condition where tissue similar to what lines the uterus grows outside of it, leading to pain and other symptoms. Elagolix is a medicine taken orally that stops this tissue from growing. It does this by blocking a hormone that tells the tissue to grow, which then lowers the body's levels of estrogen and progesterone.

When to interrupt dosage

The recommended measure of Orilissa is contingent upon the diagnosed affliction, including Menorrhagia, Endometriosis and Endometriosis. The dosage fluctuates as per the technique of delivery (e.g. Tablet, film coated or Tablet) detailed in the table beneath.

Condition

Dosage

Administration

Endometriosis

, 150.0 mg, 200.0 mg, 600.0 mg, 300.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Menorrhagia

, 150.0 mg, 200.0 mg, 600.0 mg, 300.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Uterine Fibroids

, 150.0 mg, 200.0 mg, 600.0 mg, 300.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Pain

, 150.0 mg, 200.0 mg, 600.0 mg, 300.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Warnings

Orilissa Contraindications

Condition

Risk Level

Notes

Osteoporosis

Do Not Combine

Severe Hepatic Impairment

Do Not Combine

Pulse Frequency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Elagolix may interact with Pulse Frequency

There are 20 known major drug interactions with Orilissa.

Common Orilissa Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Elagolix.

Amiodarone

Major

The metabolism of Amiodarone can be decreased when combined with Elagolix.

Amitriptyline

Major

The metabolism of Amitriptyline can be decreased when combined with Elagolix.

Amoxapine

Major

The metabolism of Amoxapine can be decreased when combined with Elagolix.

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Elagolix.

Orilissa Toxicity & Overdose Risk

Signs of an overdose on elagolix may include hot flashes, headaches, nausea, sleeplessness, changes in mood, missed or irregular periods, depression, anxiety, joint pains, bone loss, and elevated liver enzymes. Elagolix is typically taken for up to two years at the 150mg dose or up to six months at the 200mg dose, and can cause a decrease in bone mineral density with increasing duration of use. For women with moderate liver problems, the recommended dose is 150mg once daily for up to six months.

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Orilissa Novel Uses: Which Conditions Have a Clinical Trial Featuring Orilissa?

15 active trials are currently investigating the potential of Orilissa in alleviating Menorrhagia, Endometriosis and Endometrial Disease.

Condition

Clinical Trials

Trial Phases

Uterine Fibroids

7 Actively Recruiting

Early Phase 1, Not Applicable, Phase 3, Phase 4, Phase 1

Pain

0 Actively Recruiting

Menorrhagia

0 Actively Recruiting

Endometriosis

28 Actively Recruiting

Phase 3, Not Applicable, Phase 4, Early Phase 1, Phase 2, Phase 1

Orilissa Reviews: What are patients saying about Orilissa?

5

Patient Review

3/28/2022

Orilissa for Endometriosis

Endometriosis has been a issue for me for 15 years, and I've had to have six different surgeries because of it. Thankfully, this medication has finally provided some relief.

5

Patient Review

8/27/2022

Orilissa for Endometriosis

I had pelvic pain, bloating, and fatigue for 15 years. This medication started working after the first month of taking it. No more periods is amazing! Worst side effect was hot flashes. A true miracle medication that has given me my life back!

4.7

Patient Review

11/8/2021

Orilissa for Endometriosis

I have been on this medication for over a year now and I am really surprised by all the negative reviews I am reading. I have not experienced any headaches, nausea, or hot flashes. This medicine has worked great for me and my period pain is gone! With my insurance, I only pay five dollars for a month supply.

2

Patient Review

11/4/2021

Orilissa for Endometriosis

I experienced significant memory loss and depression while on this medication. Additionally, it did not help with my pain or menstrual cycles as intended. I'm writing this review in hopes of helping others avoid the same issues I went through.

1.7

Patient Review

10/12/2021

Orilissa for Endometriosis

I was prescribed this medication from my Gyn because of my severe painful menstruation. I started in July 2021. Instantly felt the side effects - joint pains, feet and hands were always numb, hot flashes.. When I decided to stop taking orilissa, my endometriosis got worse..Dealing with excruciation pain everyday on the right side of my abdomen and radiates to my rectum. I have to take pain meds to go on with my day otherwise I can't function. Life is no longer normal. very sad!
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Patient Q&A Section about orilissa

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you gain weight on Orilissa?

"If you gain weight while taking Orilissa, it's not something to worry about, as it's not a common side effect. However, if you're concerned about your weight, talk to your doctor, who can recommend ways to maintain a healthy weight."

Answered by AI

What is Orilissa used for?

"ORILISSA is a medicine used to treat moderate to severe pain associated with endometriosis in adults. It is not known if it is safe and effective in children."

Answered by AI

What type of drug is Orilissa?

"Orilissa is a drug that works by reducing levels of certain hormones, such as estrogen, in the body. Mirena is a drug that contains a progestin hormone. These drugs work differently to reduce levels of certain hormones in the body."

Answered by AI

What does Orilissa do to your body?

"Orilissa prevents GnRH from having any effect. GnRH is a hormone that is produced by the brain. When GnRH is released, it starts a chain of events that tell the body to produce hormones like estrogen and progesterone. These are the two main sex hormones responsible for the menstrual cycle."

Answered by AI

Clinical Trials for Orilissa

Image of Alethios in San Francisco, United States.

Fiber Supplement for Endometriosis

18 - 45
Female
San Francisco, CA

This study is a double-blind, randomized, placebo-controlled study that evaluates the safety and tolerability of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to evaluate the safety and tolerability of the supplement, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fibers impact on gastrointestinal symptoms and quality of life through the use of custom questionnaires built for the study population and evaluation of other endometriosis related parameters such as pelvic discomfort. Exploratory objectives focus on the exploration of the gut and vaginal microbiomes, their connection to endometriosis, and how they are impacted by the study product.

Recruiting
Paid Trial

Alethios

Bryce Jarman, PhD

Alethios, Inc.

Image of University of Alberta in Edmonton, Canada.

Pelvic Floor Physical Therapy for Endometriosis

18 - 50
Female
Edmonton, Canada

Endometriosis is a chronic inflammatory condition where there is abnormal tissue growing in the pelvis or other places in the body that resembles the lining of the uterus (endometrium), and is a common cause of long lasting pelvic pain. Surgery is sometimes done for endometriosis to help people with pain, however it is common for people to have some pain after surgery that doesn't go away. This may be related to other painful things like muscle pain in the pelvis, bowel or bladder issues, or mental health conditions. Researchers would like to know if doing pelvic floor physiotherapy before surgery for endometriosis will help people with long lasting pain after surgery. Participants in the study will be randomly put into one of two groups: the intervention group, who will receive two to three structured in-person pelvic floor physiotherapy sessions prior to surgery ("prehabilitation"), in addition to usual surgical care, or the control group, who will receive usual surgical care, and may still access physiotherapy outside of the study if they want to. All participants will complete questionnaires before surgery, after completing prehabilitation or immediately before surgery if they are part of the control group, approximately 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. The questionnaires ask about endometriosis-related pain, quality of life, bladder and bowel symptoms, and mental well-being.

Waitlist Available
Has No Placebo

University of Alberta

Alicia Long, MD, MSc, FRCSC

Image of Icahn School of Medicine at Mount Sinai in New York, United States.

Personalized Exercise for Chronic Pelvic Pain

18 - 55
Female
New York, NY

WorkoutCPP is a pilot study evaluating the feasibility of a personalized exercise recommendation system for individuals with chronic pelvic pain disorders (CPPDs). The study uses reinforcement learning (RL), a type of artificial intelligence that adapts recommendations over time based on each participant's reported pain levels, symptom burden, and exercise compliance. Participants receive daily exercise recommendations that alternate between standard, non-personalized guidance and personalized, RL-generated recommendations across four 2-week phases, allowing within-person comparison of outcomes under each condition. The primary hypothesis is that an RL-based adaptive recommendation system is feasible to deliver in a CPPD population.

Recruiting
Has No Placebo

Icahn School of Medicine at Mount Sinai

Ipek Ensari, PhD

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Podcast for Pelvic Pain

18+
Female
Nashville, TN

The purpose of this research study is to study the impact of an educational podcast on pelvic pain. If you decide to take part in this research, you may receive the standard treatment for pelvic pain, or you may receive the standard treatment plus access to an educational podcast series. You will be randomly assigned to receive access to the podcast or to receive standard care. If you are assigned to receive access to the podcast, participating in this research will involve listening to a podcast series. All participants will complete three ten-minute online surveys over the course of 6 months. Reasons you may choose to participate in this research are if you want to learn more about pelvic pain and possible benefits of listening to the podcast, such as improved quality of life, reduced stigma, or increased satisfaction with your medical care.

Recruiting
Has No Placebo

Vanderbilt Center for Women's Health

Image of Evanston Hospital in Evanston, United States.

Vaginal Sildenafil for Menstrual Pain

18 - 35
Female
Evanston, IL

This open-label, non-randomized mechanistic study will evaluate whether a single 100 mg vaginal sildenafil citrate suppository reduces uterine hypercontractility during menstruation in adults with moderate-to-severe dysmenorrhea. Ten participants will each receive one open-label dose during a single menstrual treatment visit and will serve as their own control: 6 participants with primary dysmenorrhea and no evidence of pelvic pathology, plus a separately analyzed exploratory subset of 4 participants, 2 with known endometriosis and 2 with known uterine fibroids. Uterine contractility will be measured with cine magnetic resonance imaging (MRI) before dosing and approximately 4 hours after dosing. Additional objectives are to evaluate acute menstrual pain over the 4-hour observation window, to document systemic exposure using sparse plasma sampling at approximately 2 and 4 hours after dosing, and to assess short-term safety and local tolerability.

Phase 1
Waitlist Available

Evanston Hospital

Frank Tu, MD, MPH

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We made a collection of clinical trials featuring Orilissa, we think they might fit your search criteria.
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Metformin for Endometriosis

15 - 35
Female
Boston, MA

The goal of this pilot trial is to learn if a novel non-hormonal treatment, metformin hydrochloride, works to treat pelvic pain in young women with endometriosis. The main questions it aims to answer are: * Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis? * Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis? Researchers will compare metformin to a placebo (a look-alike substance that contains no drug) to see if metformin works to treat pelvic pain. Participants will: * Take drug metformin or a placebo every day for 6 months * Visit the clinic three times: once at baseline (pre-treatment), once at 3 months, and once at 6 months * Keep a daily symptom diary to track pain, bleeding, and usage of any pain medications

Phase 2
Waitlist Available

Boston Children's Hospital

Jessica Shim, MD

Have you considered Orilissa clinical trials?

We made a collection of clinical trials featuring Orilissa, we think they might fit your search criteria.
Go to Trials