Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
NCT ID: NCT00237523
Last Updated: 2007-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
175 participants
INTERVENTIONAL
2005-07-31
2008-03-31
Brief Summary
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* 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).
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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IoGen (molecular iodine)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Symbollon Pharmaceuticals
INDUSTRY
Principal Investigators
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Julia Kazakhin, M.D.
Role: STUDY_DIRECTOR
Symbollon Pharmaceuticals, Inc.
Locations
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Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Women's Health Research
Phoenix, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
Expresscare Clinical Research
Colorado Springs, Colorado, United States
Downtown Women's Heath Care
Denver, Colorado, United States
University of Colorado
Denver, Colorado, United States
S.H.E. Medical Associates
Hartford, Connecticut, United States
The GYN's Center for Women's Health
Waterbury, Connecticut, United States
Greater Hartford Women's Health Associates
West Hartford, Connecticut, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Miami Research Associates, Inc.
Miami, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, United States
Women's Health Practice
Champaign, Illinois, United States
Physicians Research Group
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Kentucky Medical Research Center
Lexington, Kentucky, United States
York Clinical Consulting
Marrero, Louisiana, United States
MedVadis Research
Wellesley, Massachusetts, United States
Fallon Clinic
Worcester, Massachusetts, United States
University of Missouri
Kansas City, Missouri, United States
Department of Ob/Gyn - Women's Health University of Saint Louis
St Louis, Missouri, United States
The Medical Group of Northern Nevada
Reno, Nevada, United States
Women's Health Research Center, LLC
Lawrenceville, New Jersey, United States
Laurel Creek Research Associates
Moorestown, New Jersey, United States
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Radiant Research
Cincinnati, Ohio, United States
HWC Women's Research Center
Miamisburg, Ohio, United States
LION Research
Norman, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Fellows Research Alliance, Inc.
Hilton Head Island, South Carolina, United States
Women's Clinical Research Center/North Seattle Women's Group
Seattle, Washington, United States
Tacoma Women's Specialists
Tacoma, Washington, United States
Countries
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References
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Aceves C, Anguiano B, Delgado G. Is iodine a gatekeeper of the integrity of the mammary gland? J Mammary Gland Biol Neoplasia. 2005 Apr;10(2):189-96. doi: 10.1007/s10911-005-5401-5.
Cann SA, van Netten JP, van Netten C. Hypothesis: iodine, selenium and the development of breast cancer. Cancer Causes Control. 2000 Feb;11(2):121-7. doi: 10.1023/a:1008925301459.
Kessler JH. The effect of supraphysiologic levels of iodine on patients with cyclic mastalgia. Breast J. 2004 Jul-Aug;10(4):328-36. doi: 10.1111/j.1075-122X.2004.21341.x.
Ghent WR, Eskin BA, Low DA, Hill LP. Iodine replacement in fibrocystic disease of the breast. Can J Surg. 1993 Oct;36(5):453-60.
Garcia-Solis P, Alfaro Y, Anguiano B, Delgado G, Guzman RC, Nandi S, Diaz-Munoz M, Vazquez-Martinez O, Aceves C. Inhibition of N-methyl-N-nitrosourea-induced mammary carcinogenesis by molecular iodine (I2) but not by iodide (I-) treatment Evidence that I2 prevents cancer promotion. Mol Cell Endocrinol. 2005 May 31;236(1-2):49-57. doi: 10.1016/j.mce.2005.03.001. Epub 2005 Apr 13.
Eskin BA, Grotkowski CE, Connolly CP, Ghent WR. Different tissue responses for iodine and iodide in rat thyroid and mammary glands. Biol Trace Elem Res. 1995 Jul;49(1):9-19. doi: 10.1007/BF02788999.
Thrall KD, Bull RJ, Sauer RL. Distribution of iodine into blood components of the Sprague-Dawley rat differs with the chemical form administered. J Toxicol Environ Health. 1992 Nov;37(3):443-9. doi: 10.1080/15287399209531682.
Venturi S. Is there a role for iodine in breast diseases? Breast. 2001 Oct;10(5):379-82. doi: 10.1054/brst.2000.0267.
Smyth PP. Role of iodine in antioxidant defence in thyroid and breast disease. Biofactors. 2003;19(3-4):121-30. doi: 10.1002/biof.5520190304.
Ader DN, South-Paul J, Adera T, Deuster PA. Cyclical mastalgia: prevalence and associated health and behavioral factors. J Psychosom Obstet Gynaecol. 2001 Jun;22(2):71-6. doi: 10.3109/01674820109049956.
Ader DN, Shriver CD, Browne MW. Cyclical mastalgia: premenstrual syndrome or recurrent pain disorder? J Psychosom Obstet Gynaecol. 1999 Dec;20(4):198-202. doi: 10.3109/01674829909075596.
Ader DN, Browne MW. Prevalence and impact of cyclic mastalgia in a United States clinic-based sample. Am J Obstet Gynecol. 1997 Jul;177(1):126-32. doi: 10.1016/s0002-9378(97)70450-2.
Other Identifiers
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SYM1210
Identifier Type: -
Identifier Source: org_study_id