Violet Petal Study – a medical research
study for women with moderate to severe
pain caused by endometriosis.
Pain. It's a part of everyone's life – both men and women. But there is a unique type of pain that only women can know. It throbs. It aches. It goes on and on. It's the pain associated with endometriosis.
Endometriosis is a common gynecological condition in which the tissue that lines the uterus – the endometrium – is found elsewhere in the body. Symptoms range from mild to severe, and many women with the condition are often misdiagnosed or aren't diagnosed with any condition at all. This makes it difficult to determine the actual number of endometriosis cases. For those with symptoms, the most common is pelvic pain – painful periods, pain during intercourse, and painful bowel movements. A woman may also suffer pain in the abdomen and lower back.
Right now research is underway to test a new oral investigational medicaiotn
for moderate to severe pain caused by endometriosis.
About the study.
To qualify you must:
Each individual will be evaluated to determine her Violet Petal Study participation eligibility. If you qualify, you'll receive the investigational medication, study-related medical exams, and laboratory services at no charge. You may also be reimbursed for travel and other expenses.
- Be a woman age 18 to 49
- Have been surgically diagnosed with endometriosis in the last seven years
The purpose of the research study is to evaluate the safety and effectiveness of an investigational medication for the management of moderate to severe endometriosis-associated pain and other endometriosis-related symptoms. There may be physicians in your area currently conducting this research study.
Visit www.VioletPetalStudy.com to learn more
A special website has been developed to provide you with more information about the Violet Petal Study. The site includes information on what to expect as a study participant and can help you determine if you may qualify to participate. And if you know someone with endometriosis, please feel free to pass this information along to her. To learn more, visit www.VioletPetalStudy.com.
What you should know about
medical research studies.
Gain knowledge through research.
Exploring your options through a clinical research study can help you gain a better understanding of your endometriosis. As a study participant, you will get the support of the study center staff at every visit. That includes close monitoring of your endometriosis under the guidance of a gynecologist. Your participation will also help the researchers learn more about the investigational study medication.
What should I expect?
Before you participate in a study screening visit, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an "Informed Consent Form" and discussed with you. You will be asked to review and sign the Informed Consent Form prior to participating. Your medical history will be reviewed and you will receive a study-related physical exam and laboratory services.
If you qualify, you will be enrolled in the study. Once enrolled, feel free to discuss your research care with the study physician or research staff members at any time during the course of the study. Data collected during a medical research study may or may not ultimately lead to a drug being approved by the FDA or other regulatory health authorities, and may result in future developments of other drugs.
It is important to:
As a study participant, you have the right to contact your Institutional Review Board (IRB) or Ethics Committee (EC) representative regarding your rights as a research participant. You also have the right to leave the study at any time without any penalty to your current medical care.
- Attend all scheduled visits,
- Describe your feelings and well-being accurately and honestly to the study physician,
- Take the investigational medication as instructed
Study doctors and their staff respect your privacy. Details about your health will not be shared with anyone who is not associated with this research study unless you have given your permission or except as required by law. Your study visits will be held in medical offices under the supervision of a physician and conducted in compliance with all regulatory requirements.