Clinical trial for women with Interstitial Cystitis / Bladder Pain Syndrome
You can help advance the introduction of a potential new medication for IC/BPS.
Interstitial cystitis (IC), also known as bladder pain syndrome (BPS), involves bladder pain, pressure and frequent urination. Currently there is no cure for IC/BPS, and few effective treatment options exist for IC/BPS sufferers.
Our medical researchers understand the daily struggle of living with moderate to severe interstitial cystitis / bladder pain syndrome (IC/BPS). Pain and frequent urination prevent many IC/BPS sufferers from performing their daily activities.
More treatment options for IC/BPS are needed, but this can only
happen through clinical research
and the support from women like you.
About this Study
Clinical research studies are how new medicines are developed. This research study is designed to see how well an investigational study medicine works at reducing moderate-to-severe IC/BPS pain.
This study is enrolling women 18 years and older (up to 75 years) with IC/BPS. Up to 70 women across the United States and Canada will participate.
There are a variety of reasons women may choose to participate in the LEADERSHIP clinical research study: Some women may participate to have additional care and attention from the medical study staff. Others may participate to learn more about their own health and interstitial cystitis.
As with all medicines there may be the possibility of side effects. The study doctor or study staff will discuss potentially known risks and benefits of study participation before you agree to participate.
More information about the LEADERSHIP study:
If you qualify for the study, you may receive:
- The oral investigational study medicine or placebo (an inactive look-alike substance) to be taken once daily with food and water
- Acetaminophen and codeine (such as Tylenol® with codeine) to be taken as directed [if needed] for IC/BPS pain
- All study related medical care and medicines
Those who qualify will be asked to:
- Visit the study center 6 times over approximately 13 weeks (91 days)
- Carefully monitor your IC/BPS pain symptoms with the assistance of an electronic medical diary device
How the study is designed:
Placebo vs. the investigational study medicine
Study-related assessments help you and the study doctor monitor the safety and effectiveness of the investigational study medicine and compare it to placebo, which will look like the investigational study medicine but has no active ingredients (sometimes called a “sugar pill”). In order to avoid bias, no one (neither the study doctor nor you) will know if you are taking the investigational study medicine or the placebo.
Earlier Phase 1 studies with this investigational study medicine have been conducted and demonstrated the investigational study medicine is safe in healthy volunteers. Researchers are now working to better understand how well the study drug works and how well tolerated the medication is in reducing IC/BPS associated pain.
See if You Pre-Qualify
See if you pre-qualify for the LEADERSHIP study by completing our study survey. The study survey will ask you about the severity of your IC/BPS pain and symptoms. There are other questions that may determine whether you meet the study's inclusion criteria. If you pre-qualify, you will be referred to a study center of your choice.
While there must be a match based on medical history, there are other requirements including:
- Age: Women 18-75 years of age
- Symptoms: IC/BPS diagnosis with pain
- Time: Attend 6 required clinic visits over approximately 91 days / 13 weeks
- Tracking: Agree to complete a daily electronic diary of your symptoms throughout the study
- Have undergone a cystoscopy (an endoscopic procedure that helps assess the health of your bladder lining) in the last 36 months
- If the cystoscopy was performed for diagnostic purposes, it must have been performed at least one month prior
- If the cystoscopy involved therapeutic hydrodistention (i.e. pain relief), it must have been performed at least 3 months prior
If you qualify and agree to participate you may:
- Learn more about your IC/BPS and ways to manage it
- Receive at no cost, study-related medical tests to help you learn about your health and your body’s response to the investigational study medicine or placebo
- Be compensated for study-related time and travel or have transportation provided for you if necessary
There is no cost to you, and you can participate even if:
- The study doctor is not part of your health insurance network
- You do not have health insurance
Further details regarding study participation will be supplied by the study center during the screening visit.
Study Site Locations
Find the location of a study center near you. Take the IC/BPS study survey. After pre-qualifying, someone from the study center will contact you to give you more information about the study and answer any questions you might have.Click here to see if you pre-qualify >>