Pain Clinical Trial
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
Verified date | June 2007 |
Source | Symbollon Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
- 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).
Status | Active, not recruiting |
Enrollment | 175 |
Est. completion date | March 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Visions Clinical Research | Boynton Beach | Florida |
United States | Montefiore Medical Center/Albert Einstein College of Medicine | Bronx | New York |
United States | Women's Health Practice | Champaign | Illinois |
United States | Radiant Research | Cincinnati | Ohio |
United States | Women’s Medical Research Group, LLC | Clearwater | Florida |
United States | Expresscare Clinical Research | Colorado Springs | Colorado |
United States | Soapstone Center for Clinical Research | Decatur | Georgia |
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 | Penn State The Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Fellows Research Alliance, Inc. | Hilton Head Island | South Carolina |
United States | Medical Affiliated Research Center, Inc. | Huntsville | Alabama |
United States | Physicians Research Group | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Missouri | Kansas City | Missouri |
United States | Women’s Health Research Center, LLC | Lawrenceville | New Jersey |
United States | Kentucky Medical Research Center | Lexington | Kentucky |
United States | York Clinical Consulting | Marrero | Louisiana |
United States | Miami Research Associates, Inc. | Miami | Florida |
United States | HWC Women's Research Center | Miamisburg | Ohio |
United States | Laurel Creek Research Associates | Moorestown | New Jersey |
United States | LION Research | Norman | Oklahoma |
United States | Memorial Hospital of Rhode Island | Pawtucket | Rhode Island |
United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
United States | Women's Health Research | Phoenix | Arizona |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Wake Research Associates, LLC | Raleigh | North Carolina |
United States | The Medical Group of Northern Nevada | Reno | Nevada |
United States | Department of Ob/Gyn – Women’s Health University of Saint Louis | Saint Louis | Missouri |
United States | Fellows Research Alliance, Inc. | Savannah | Georgia |
United States | Women's Clinical Research Center/North Seattle Women's Group | Seattle | Washington |
United States | Tacoma Women's Specialists | Tacoma | Washington |
United States | Visions Clinical Research | Tucson | Arizona |
United States | The GYN’s Center for Women’s Health | Waterbury | Connecticut |
United States | MedVadis Research | Wellesley | Massachusetts |
United States | Greater Hartford Women's Health Associates | West Hartford | Connecticut |
United States | Palm Beach Research Center | West Palm Beach | Florida |
United States | Fallon Clinic | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Symbollon Pharmaceuticals |
United States,
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. Review. — View Citation
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. — View Citation
Ader DN, Shriver CD, Browne MW. Cyclical mastalgia: premenstrual syndrome or recurrent pain disorder? J Psychosom Obstet Gynaecol. 1999 Dec;20(4):198-202. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
García-Solís P, Alfaro Y, Anguiano B, Delgado G, Guzman RC, Nandi S, Díaz-Muñoz M, Vázquez-Martínez 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. Epub 2005 Apr 13. — View Citation
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. — View Citation
Kessler JH. The effect of supraphysiologic levels of iodine on patients with cyclic mastalgia. Breast J. 2004 Jul-Aug;10(4):328-36. — View Citation
Smyth PP. Role of iodine in antioxidant defence in thyroid and breast disease. Biofactors. 2003;19(3-4):121-30. Review. — View Citation
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. — View Citation
Venturi S. Is there a role for iodine in breast diseases? Breast. 2001 Oct;10(5):379-82. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total clinical breast pain as documented by patient daily diary. | |||
Secondary | Change in fibrosis based upon breast examination. |
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