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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00237523
Other study ID # SYM1210
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received October 7, 2005
Last updated June 15, 2007
Start date July 2005
Est. completion date March 2008

Study information

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

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
IoGen (molecular iodine)


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Symbollon Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. 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 allClick here to view all references

Outcome

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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