Orilissa

Endometriosis, Menorrhagia, Uterine Fibroids + 1 more
Treatment
20 Active Studies for Orilissa

What is Orilissa

ElagolixThe Generic name of this drug
Treatment SummaryElagolix (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.
Orilissais 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 PatientsIn 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 bodyEndometriosis 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 RiskSigns 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
13 Actively Recruiting
Phase 2, Early Phase 1, Phase 3, Not Applicable, Phase 4
Pain
0 Actively Recruiting
Menorrhagia
0 Actively Recruiting
Endometriosis
27 Actively Recruiting
Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4

Orilissa Reviews: What are patients saying about Orilissa?

5Patient 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.
5Patient 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!
4.7Patient 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.
2Patient 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.
1.7Patient 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 University Hospitals Cleveland Medical Center in Cleveland, United States.

Ketamine for Pelvic Pain

18 - 89
Female
Cleveland, OH
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
Phase 4
Waitlist Available
University Hospitals Cleveland Medical CenterMorgan Cheeks, 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
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Educational Video for Uterine Fibroids

18 - 55
All Sexes
Philadelphia, PA
Uterine fibroids are a common condition that can cause heavy and/or painful menstrual bleeding. There are many treatment options, but they vary in efficacy, side effects, short-term recovery and long-term implications for future fertility. Patients can have difficulty deciding between these options. In this study, the investigators will randomly assign patients seeking treatment for fibroids to receive an educational video on fibroids and their treatment, versus usual care (no video). The investigators will assess their decisional conflict with and without exposure to the video using a validated survey to see if exposure to the educational video helps them make decisions.
Recruiting
Has No Placebo
Hospital of the University of PennsylvaniaAnuja Dokras, MD
Image of MedStar Washington Hospital Center in Washington, United States.

Chromopertubation for Uterine Fibroids

18+
Female
Washington, United States
This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids. Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction. Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy. This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.
Recruiting
Has No Placebo
MedStar Washington Hospital Center (+1 Sites)
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NettleEndo for Endometriosis

22 - 45
Female
San Francisco, CA
The goal of this clinical trial is to learn if a wearable brain stimulation device called NettleEndo can reduce chronic pelvic pain and improve wellbeing in women with endometriosis. The study also aims to assess the safety and usability of the device when used at home over several months. The main questions it aims to answer are: 1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality? Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms. Participants will: 1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Wear an optional fitness tracker to collect data on sleep, movement, and heart rate variability 5. Be followed for 60 days after completing the intervention to monitor longer-term effects All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.
Recruiting
Online Trial
Alethios, Inc.Nirav Shah, MD, MPHSamphire Group, Inc.
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Dronabinol for Endometriosis

18 - 64
Female
Hosuton, TX
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
Phase 2
Waitlist Available
Baylor College of Medicine (+1 Sites)Christopher Verrico, PhD in Pharmacology
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
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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
Recruiting
Boston Children's HospitalJessica Shim, MD
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Peer Empowered Endometriosis Pain Support for Endometriosis

18 - 48
Female
Saint Louis, MO
The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care program, decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48. The main question we aim to answer is: Is PEEPS more effective than Education in decreasing pain interference? Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain, physical function, and quality of life. Participants will: * Complete baseline quality of life surveys * Participate in an 8-session group care program * Provide feedback on each session and the program globally * Complete follow up quality of life surveys at PEEPS completion, 6- and 12-months post-completion. * A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS
Recruiting
Has No Placebo
WashU Medicine (+1 Sites)Whitney Ross, MD
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Methadone for Uterine Fibroids

18+
Female
Baltimore, MD
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse. Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).
Phase 2
Recruiting
The Johns Hopkins Bayview Medical Center (+1 Sites)Mostafa Borahay, MD, MBA, PhD
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
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