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Q: What is Clinical Breast Pain? A: Breast pain, or mastalgia, in most cases is a benign breast syndrome. Survey data suggested that about 65% of premenopausal women regularly experience up to 4 days of breast pain, tenderness and/or swelling during menstrual cycle. Breast pain may be associated with the menstrual cycle (cyclic mastalgia) or not (non-cyclic mastalgia). Physicians recognize two types of cyclic breast pain based on pain severity and length: symptomatic pain, which is considered "normal" and lasts up to 4 days, and "clinical" which is more severe, prolonged (6 days and longer) type of pain. Cyclic breast pain occurs in both breasts and it may differ from month to month but always gets worse before a period and it may be associated with breast lumps and/or breast thickening, sometimes referred to as FBD. Q: What is the Purpose of These Studies? A:These studies are designed to evaluate the effectiveness of a novel iodine-based product, IoGen, (currently available for purchase at www.BuyIoGen.com) in treatment of clinical, moderate or severe, breast pain associated with fibrocystic breast disease. Previous human clinical studies suggested that IoGen can effectively treat the symptoms associated with fibrocystic breast disease. Q: Who May Qualify for the Studies? A: We are seeking clinical research volunteers to join future studies of a dietary supplement, IoGen. Non-pregnant or non-lactating women between 18 and 50 years of age who have cyclic, clinical breast pain associated with fibrocystic breast disease are eligible to participate in these studies. Qualified volunteers have to agree to use a medically acceptable birth control method during the study. The birth control options for these studies are: oral contraceptives (like "the pill"), contraceptive injections, intrauterine devices, double-barrier methods (diaphragm or condom plus spermicidal cream), contraceptive patches, or male partner sterilization. If you are considering participation in this clinical study, we encourage you to discuss any questions or concerns you may have with your doctor. Your decision is voluntary and should be based on personal needs and interests. Q: Who is Paying for These Studies? A:The study doctor or study center is being paid by the pharmaceutical company that is providing the study product for these studies. If these studies are determined to be a good match for you after you take the pre-screening survey, your information will be sent to a study doctor near you who can give you additional details about these studies. Q: May I Be Excluded From These Studies? A: Researchers need to evaluate IoGen in people whose medical histories are quite similar. This helps the researchers determine if IoGen is working. Some of the answers you give to the questions asked on this website may indicate that the studiesī criteria do not fit your profile and you are not a good match for these studies. Q: When will I know if I am Eligible? A: You may complete the prescreening process on this website or by calling the study toll-free number 1-888-817-9622. All final decisions regarding eligibility will be made by the study center in your area. Q: How is My Medical Information Kept Confidential? A:Reasonable steps will be taken to keep all collected information confidential. Only with your permission, information collected for these studies will be given to medical personnel at a clinic in your area. Please read our Privacy Policy Notice. Q: Are the study medication and medical care free? A: All qualifies and enrolled volunteers will receive IoGen and study related evaluations at no charge. Q: Will I get paid to participate in the study? A:Participants will be compensated for the time and travel. |
