Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
This trial is active, not recruiting.
|Conditions||fibrocystic disease of breast, fibrocystic changes of breast, fibrocystic mastopathy, pain|
|Treatment||iogen (molecular iodine)|
|Start date||July 2005|
|End date||March 2008|
|Trial size||175 participants|
|Trial identifier||NCT00237523, SYM1210|
- History of clinical breast pain for at least the last six months.
- At least six days of moderate or severe breast pain per cycle.
- Fibrosis, cysts, nodules involving at least 25% of the surface of one breast.
- Euthyroid with no prior history of thyroid disease.
- Six months of daily therapy with molecular iodine.
- Placebo controlled vs active (1:1).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Huntsville, AL||Medical Affiliated Research Center, Inc.||no longer recruiting|
|Phoenix, AZ||Women's Health Research||no longer recruiting|
|Tucson, AZ||Visions Clinical Research||no longer recruiting|
|Colorado Springs, CO||Expresscare Clinical Research||no longer recruiting|
|Denver, CO||University of Colorado||no longer recruiting|
|Denver, CO||Downtown Women's Heath Care||no longer recruiting|
|Hartford, CT||S.H.E. Medical Associates||no longer recruiting|
|Waterbury, CT||The GYN’s Center for Women’s Health||no longer recruiting|
|West Hartford, CT||Greater Hartford Women's Health Associates||no longer recruiting|
|Boynton Beach, FL||Visions Clinical Research||no longer recruiting|
|Clearwater, FL||Women’s Medical Research Group, LLC||no longer recruiting|
|Miami, FL||Miami Research Associates, Inc.||no longer recruiting|
|West Palm Beach, FL||Palm Beach Research Center||no longer recruiting|
|Decatur, GA||Soapstone Center for Clinical Research||no longer recruiting|
|Savannah, GA||Fellows Research Alliance, Inc.||no longer recruiting|
|Champaign, IL||Women's Health Practice||no longer recruiting|
|Indianapolis, IN||Physicians Research Group||no longer recruiting|
|Iowa City, IA||University of Iowa||no longer recruiting|
|Lexington, KY||Kentucky Medical Research Center||no longer recruiting|
|Marrero, LA||York Clinical Consulting||no longer recruiting|
|Wellesley, MA||MedVadis Research||no longer recruiting|
|Worcester, MA||Fallon Clinic||no longer recruiting|
|Kansas City, MO||University of Missouri||no longer recruiting|
|Saint Louis, MO||Department of Ob/Gyn – Women’s Health University of Saint Louis||no longer recruiting|
|Reno, NV||The Medical Group of Northern Nevada||no longer recruiting|
|Lawrenceville, NJ||Women’s Health Research Center, LLC||no longer recruiting|
|Moorestown, NJ||Laurel Creek Research Associates||no longer recruiting|
|Bronx, NY||Montefiore Medical Center/Albert Einstein College of Medicine||no longer recruiting|
|Raleigh, NC||Wake Research Associates, LLC||no longer recruiting|
|Cincinnati, OH||Radiant Research||no longer recruiting|
|Miamisburg, OH||HWC Women's Research Center||no longer recruiting|
|Norman, OK||LION Research||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
|Hershey, PA||Penn State The Milton S. Hershey Medical Center||no longer recruiting|
|Philadelphia, PA||Drexel University College of Medicine||no longer recruiting|
|Pawtucket, RI||Memorial Hospital of Rhode Island||no longer recruiting|
|Hilton Head Island, SC||Fellows Research Alliance, Inc.||no longer recruiting|
|Seattle, WA||Women's Clinical Research Center/North Seattle Women's Group||no longer recruiting|
|Tacoma, WA||Tacoma Women's Specialists||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Total clinical breast pain as documented by patient daily diary.
Change in fibrosis based upon breast examination.
Female participants from 18 years up to 50 years old.
Inclusion Criteria: - History of clinical breast pain. - Documentation of 6 or more sequential days of moderate or severe pain by patient daily diary. - Conservative measures such as local heat, non-prescription analgesics, and properly fitted garments are not effective for the treatment of symptoms - Euthyroid with no prior history of thyroid disease. - Premenopausal female between the ages of 18 and 50. - The presence of at least one palpable structure (nodules, cysts) and involvement (diffuse nodularity or breast thickening) of at least 25% of at least one breast surface. Exclusion Criteria: - History of thyroid disease - Non-cyclic breast pain - Treatment with gonadotropin releasing hormone (GnRH) agonist, Danocrine, tamoxifen, raloxifene, or bromocriptine within three months of starting the trial - Initiation or change of any hormonal therapy within 6 months of enrollment; including birth control pills, hormone replacement therapy, any progestin including Norplant or Depo-Provera; - Current treatment with iodine or iodine-containing medications or diagnostics - Known hypersensitivity to iodine-containing products - Breast implants; - Oophorectomy (complete or partial) - Uncontrolled hypertension; - Breast biopsy breast biopsy within two months of screening; or expectation of a breast biopsy during the study for a suspicious mass present at baseline; - Pregnant women or nursing mothers - History of malignancy within the previous 5 years other than basal cell or squamous cell carcinoma of the skin - History of breast cancer
|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|
|Description||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.|
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