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 This Study?
A: The study is designed to evaluate the effectiveness
of a novel iodine-based drug, IoGen, in treatment of clinical, moderate
or severe, breast pain associated with fibrocystic breast disease.
Participants will receive either a trial drug or placebo pill (which
contains no active medication) for 6 months. Participation in the
study will require 2 initial screen visits, qualified participants
will be asked to schedule 6 more study visits and to complete a short
daily pain diary while they are on the study. Three previous human
clinical studies suggested that iodine 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 a study of an investigational medication. 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 this study. Qualified volunteers have to agree to use a medically
acceptable birth control method during the study. The birth control
options for the study 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 medications
for this study. If this study is 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 study supporters.
Q: May I Be Excluded From These Studies?
A: Researchers need to evaluate the study medication
in people whose medical histories are quite similar. This helps the
researchers determine if the study medication is working. Some of
the answers you give to the questions asked on this website may indicate
that the study’s criteria do not fit your profile and you are
not a good match for the current study.
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 this study 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
study medication 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.
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