A Phase 3 interventional study of IoGen (molecular iodine) in Fibrocystic Disease of Breast, Fibrocystic Changes of Breast and Fibrocystic Mastopathy, sponsored by Symbollon Pharmaceuticals. Status unknown at 39 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2007-06-18.
Sponsored by Symbollon Pharmaceuticals · Phase 3, Interventional, and Treatment
Primary efficacy parameters will be measured by patient self-assessment of pain/tenderness using a categorical daily pain diary. Clinical pain is defined as a patient assessment of moderate or severe pain for any given day. Total clinical pain per menstrual cycle is calculated based upon the categorical ratings recorded in a patient's daily pain diary over the course of a complete menstrual cycle.
A directed breast examination will be used as a secondary efficacy endpoint. Changes in the brest examination will be determined by the physician after consideration of both the nature of the examination findings and the surface area of breast involvement. Changes as noted after six months of therapy, relative to the screening visit (baseline) will be used to evaluate this endpoint.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 175 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →This is the only study on the registry with Symbollon Pharmaceuticals as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Total clinical breast pain as documented by patient daily diary.
Change in fibrosis based upon breast examination.
This study is status unknown, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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