Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
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
1 other identifier
interventional
175
1 country
39
Brief Summary
- 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2005
Typical duration for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJune 18, 2007
June 1, 2007
October 7, 2005
June 15, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total clinical breast pain as documented by patient daily diary.
Secondary Outcomes (1)
Change in fibrosis based upon breast examination.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Visions Clinical Research
Tucson, Arizona, 85712, United States
Expresscare Clinical Research
Colorado Springs, Colorado, 80909-1691, United States
Downtown Women's Heath Care
Denver, Colorado, 80218, United States
University of Colorado
Denver, Colorado, 80262, United States
S.H.E. Medical Associates
Hartford, Connecticut, 06105, United States
The GYN's Center for Women's Health
Waterbury, Connecticut, 06708, United States
Greater Hartford Women's Health Associates
West Hartford, Connecticut, 06117, United States
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Miami Research Associates, Inc.
Miami, Florida, 33143, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Soapstone Center for Clinical Research
Decatur, Georgia, 30034, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Kentucky Medical Research Center
Lexington, Kentucky, 40504, United States
York Clinical Consulting
Marrero, Louisiana, 70072, United States
MedVadis Research
Wellesley, Massachusetts, 02481, United States
Fallon Clinic
Worcester, Massachusetts, 01608, United States
University of Missouri
Kansas City, Missouri, 64108, United States
Department of Ob/Gyn - Women's Health University of Saint Louis
St Louis, Missouri, 63117, United States
The Medical Group of Northern Nevada
Reno, Nevada, 89502, United States
Women's Health Research Center, LLC
Lawrenceville, New Jersey, 08648, United States
Laurel Creek Research Associates
Moorestown, New Jersey, 08057, United States
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
HWC Women's Research Center
Miamisburg, Ohio, 45342, United States
LION Research
Norman, Oklahoma, 73071, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Penn State The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102-1192, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Fellows Research Alliance, Inc.
Hilton Head Island, South Carolina, 29926, United States
Women's Clinical Research Center/North Seattle Women's Group
Seattle, Washington, 98105, United States
Tacoma Women's Specialists
Tacoma, Washington, 98405, United States
Related Publications (12)
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.
PMID: 16025225BACKGROUNDCann 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.
PMID: 10710195BACKGROUNDKessler 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.
PMID: 15239792BACKGROUNDGhent WR, Eskin BA, Low DA, Hill LP. Iodine replacement in fibrocystic disease of the breast. Can J Surg. 1993 Oct;36(5):453-60.
PMID: 8221402BACKGROUNDGarcia-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.
PMID: 15922087BACKGROUNDEskin 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.
PMID: 7577324BACKGROUNDThrall 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.
PMID: 1433379BACKGROUNDVenturi S. Is there a role for iodine in breast diseases? Breast. 2001 Oct;10(5):379-82. doi: 10.1054/brst.2000.0267.
PMID: 14965610BACKGROUNDSmyth PP. Role of iodine in antioxidant defence in thyroid and breast disease. Biofactors. 2003;19(3-4):121-30. doi: 10.1002/biof.5520190304.
PMID: 14757962BACKGROUNDAder 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.
PMID: 11446156BACKGROUNDAder 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.
PMID: 10656154BACKGROUNDAder 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.
PMID: 9240595BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Julia Kazakhin, M.D.
Symbollon Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
July 1, 2005
Study Completion
March 1, 2008
Last Updated
June 18, 2007
Record last verified: 2007-06