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Sponsored by: |
Symbollon Pharmaceuticals |
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Information provided by: | Symbollon Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00237523 |
Condition | Intervention | Phase |
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Fibrocystic Disease of Breast Fibrocystic Changes of Breast Fibrocystic Mastopathy Pain |
Drug: IoGen (molecular iodine) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of IoGen™ for the Treatment of Moderate or Severe, Periodic Breast Pain Associated With Symptomatic Fibrocystic Breast Disease |
Estimated Enrollment: | 175 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | March 2008 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Julia Kazakhin, M.D. | Symbollon Pharmaceuticals, Inc. |
Study ID Numbers: | SYM1210 |
Study First Received: | October 7, 2005 |
Last Updated: | June 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00237523 |
Health Authority: | United States: Food and Drug Administration |
Breast pain Mastalgia Cyclic mastalgia Periodic mastalgia Non-cyclic mastalgia Fibrosis |
Nodularity Cysts Fibrocystic breast disease Fibrocystic breast condition Fibocystic breast syndrome |
Fibrocystic Breast Disease Skin Diseases Fibrosis Pain Cysts Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases |
Genetic Diseases, Inborn Lung Diseases Iodine Pancreatic Diseases Infant, Newborn, Diseases Cystic fibrosis Breast Diseases |
Anti-Infective Agents Anti-Infective Agents, Local Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |