A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain
This research study is looking into a new medication called OG-6219, in tablet form, designed to help women aged 18 to 49 who suffer from moderate to severe pain due to endometriosis. The study will test three different dose levels of OG-6219. Participants will be randomly assigned to receive either one of the active doses or a placebo, which is a tablet with no active medicine, like a dummy pill. This is done to fairly compare the new drug's effects. Researchers will carefully check how well the treatment reduces endometriosis-related pain and monitor for any side effects. The aim is to understand if OG-6219 is both effective and safe for managing this condition.
At a glance
What is this study about?
This study is focusing on a health condition called endometriosis, which can cause significant pain for many women. The goal of this research is to test a new tablet medicine, known as OG-6219, to see if it can help improve this pain. Researchers want to find out how effective this new medicine is compared to a dummy pill (placebo) and also to understand if it's safe to use.
Participants in the study, who are women aged 18 to 49 with moderate to severe endometriosis pain, will be divided into different groups. Some groups will receive different doses of the new medicine, while another group will receive a placebo. Neither the participants nor their doctors will know who is getting which treatment, which helps to keep the results fair and unbiased. The study will look at how much pain is reduced and will carefully record any side effects.
By comparing the dummy pill with the new medicine, scientists can learn if OG-6219 truly makes a difference in managing endometriosis pain. They will also keep a close eye on various health markers, like blood tests and vital signs, to ensure participants' safety throughout the study.
Key takeaways
- Tests a new tablet (OG-6219) for endometriosis pain.
- Compares three different doses against a dummy pill.
- Aims to check both how well it works and if it's safe.
- For women aged 18-49 with moderate to severe pain.
- You won't know if you're getting the active drug or placebo.
Who may be eligible?
This study is specifically looking for women who are between 18 and 49 years old.
To be considered, you must have been diagnosed with moderate to severe pain caused by endometriosis. This means your endometriosis pain is a significant concern for you.
More detailed criteria about your specific health history, current medications, and other medical conditions would be discussed with the study team to confirm if you're a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 49 years old?
- Have you been diagnosed with endometriosis?
- Do you experience moderate to severe pain related to your endometriosis?
- Are you able to attend regular clinic visits for the study?
What does participation involve?
If you decide to take part in this study, you will receive either the new study medication, OG-6219, at one of three different doses, or a placebo (a tablet with no active medicine). You won't know which one you are taking, and neither will your doctor, which is a common and important part of clinical trials.
The study involves regular visits to the clinic for assessments. These visits will include checks of your overall health, such as blood tests, measuring your blood pressure and heart rate (vital signs), and physical examinations. You will also be asked to regularly report on your pain levels and any other symptoms you experience. This will help the researchers understand how the medication is affecting your endometriosis-related pain.
Throughout the study, you'll be carefully monitored for any side effects or changes in your health. The total time you'd be involved in the study and the exact number of visits would be explained in full detail by the study team.
Potential risks and benefits
Locations (10)
- —UnverifiedBulgaria
- —UnverifiedLatvia
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedSweden
- —UnverifiedFrance
Common questions
What is endometriosis?
Endometriosis is a condition where tissue similar to the lining of the womb grows outside of it, causing pain and other symptoms.
What is a 'placebo'?
A placebo is a dummy pill that looks like the study drug but contains no active medicine. It helps researchers compare the true effects of the new drug.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know whether you are receiving the active drug or the placebo. This is to ensure the study results are fair.
What kind of checks will I have during the study?
You'll have regular health checks, including blood tests, checks of your heart rate and blood pressure, and physical exams to monitor your health and how the treatment is affecting you.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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