Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00237523
• Other study ID #: SYM1210
• 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
• 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

Related Conditions & MeSH terms

• Breast Diseases
• Cystic Fibrosis
• Fibrocystic Changes of Breast
• Fibrocystic Disease of Breast
• Fibrocystic Mastopathy
• Mastodynia
• Pain

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 all — Click 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.