The Edelweiss study is assessing the safety and effectiveness of an investigational drug alone and in combination with hormonal add-back therapy compared to placebo in women with moderate to severe pain associated with endometriosis.
Who can participate?
About 450 women are expected to participate. You may qualify if you:
- Are 18 to 49 years old
- Have had a surgically confirmed diagnosis of endometriosis within the last 10 years
- Have endometriosis-associated pain during your period and at other times during your menstrual cycle
- Are not pregnant, breastfeeding, or planning to become pregnant
- Meet additional requirements as determined by a screening process
Where do I begin?
The first step involves answering a few questions in an online prescreening questionnaire to see if you are a potential candidate for the study. Depending on your answers, you may be referred to a study clinic for additional screening.Answer Questions
How can I be sure that I understand the study?
You will review the consent document with the study doctor or staff. You should ask as many questions as needed to make sure you understand what will happen during your study participation. If your questions and concerns are fully addressed and you understand all aspects of the study and want to continue to the additional screening, you will need to sign the informed consent form. Throughout your study participation, you should talk to the study doctor or staff when you have questions or concerns about any aspects of the study.
What will happen during the screening?
The study doctor and staff will assess your qualifications for participation. You will be asked about your medical history, treatments and medications, and other issues that may affect your ability to participate in the study. You will also need to:
- Undergo assessments to determine if you qualify to participate in the study
- Submit daily entries in a study-provided electronic diary, e-diary for short
What happens if I qualify to participate in the study?
Day 1 Visit
The study doctor will confirm that you qualify to participate in the study. You will then be assigned by chance (like the flip of a coin) to receive one of three possible study treatments. You will take your first dose of study treatment at the clinic and complete assessments to collect baseline information at the start of your participation.
Study Treatment Kits
Beginning with the Day 1 visit, you will receive study treatment kits with instructions on how to use them. Each day of the 6-month treatment period, you will follow the instructions to take your assigned study treatment at about the same time each day.
Other drugs and supplements
The study doctor will prescribe or provide analgesics (pain medications) that you will be permitted to take during the study. You will also take vitamin D and calcium supplements daily.
After the Day 1 visit, the treatment period will include 6 more visits for study assessments to monitor your health and collect information for research purposes.
Throughout your study participation, you will complete daily entries in the study-provided e-diary, answering symptom-related questions and recording your intake of study treatments, supplements, and permitted analgesics.
You will undergo study assessments at each study visit to help the study doctor and staff monitor your health and collect information for research purposes. The study doctor and staff will review these assessments with you in detail and address your questions and concerns.
During the 6-month follow-up period, you will not take any study treatment, but you will continue to take vitamin D and calcium supplements and permitted analgesics, submit e-diary entries, and attend monthly study visits.
What drug is being tested?
The investigational drug is Linzagolix, which is:
- Designed to reduce the production of certain hormones
- Not currently approved by health authorities for treatment of moderate to severe pain associated with endometriosis
In phase 1 and phase 2 studies, Linzagolix has been shown to reduce pain associated with endometriosis with a good safety and tolerability profile.
What is hormonal add-back therapy?
Add-back therapy may lessen side effects of hormone reduction. It is often used for menopause symptom relief.
What is the placebo?
The placebo looks like the investigational drug or add-back therapy but contains no active ingredients. Placebos are used to help evaluate the investigational drug by comparing the effects seen in study participants who take the investigational drug versus those who take placebo.
Will I receive the investigational drug?
If you qualify to participate, you will be assigned by chance (like the flip of a coin) to get one of the following study treatments:
- Investigational drug (75 mg) + placebo
- Investigational drug (200 mg) + add-back therapy
- Placebo + placebo
You will have an equal chance of being assigned each study treatment.
Can I continue taking pain medications?
The study doctor will prescribe or provide analgesics (pain medications) that you will be permitted to take during the study.
What are my responsibilities in the study?
Clinical studies rely on the cooperation of volunteer participants. While you are taking part in this study, you will need to:
- Follow instructions from the study doctor and staff
- Ask questions if you have concerns or need clarification
- Follow instructions for taking your study treatment once daily
- Attend all study visits and complete scheduled assessments
- Let us know if you need to reschedule a study visit
- Submit e-diary entries daily and bring your e-diary to all visits
- Bring your study kits and empty drug containers to each visit
- Always carry your study participant card with you
- Talk with the study doctor BEFORE taking any new medications or supplements
- Keep your contact information current with the study staff
- Tell the study doctor or staff about changes to your health, even if you don’t think the changes are important
- Tell the study doctor or staff IMMEDIATELY if you believe you are pregnant or plan to become pregnant
- Use non-hormonal double barrier contraception at all times
Can I leave the study after I start?
You can stop taking part in this study at any time. If you choose not to take part or you agree to take part but then withdraw, medical care you receive outside the study will not be affected. The study doctor will discuss other treatment options with you.
Will I be paid for participating?
You will receive all study medications and study-related tests and procedures at no cost. You may also qualify for reimbursement of time and travel expenses related to your participation.
We encourage you to discuss the Edelweiss study with your doctor.