Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain - Full Text View

Purpose

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).

Condition	Intervention	Phase
Fibrocystic Disease of Breast Fibrocystic Changes of Breast Fibrocystic Mastopathy Pain	Drug: IoGen (molecular iodine)	Phase 3


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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Breast Diseases

Drug Information available for: Iodine

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Symbollon Pharmaceuticals:

Primary Outcome Measures:

Total clinical breast pain as documented by patient daily diary.

Secondary Outcome Measures:

Change in fibrosis based upon breast examination.


Estimated Enrollment:	175
Study Start Date:	July 2005
Estimated Study Completion Date:	March 2008

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237523

Show 39 Study Locations

Sponsors and Collaborators

Symbollon Pharmaceuticals

Investigators


Study Director:	Julia Kazakhin, M.D.	Symbollon Pharmaceuticals, Inc.

More Information

Publications:

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.

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.

Kessler JH. The effect of supraphysiologic levels of iodine on patients with cyclic mastalgia. Breast J. 2004 Jul-Aug;10(4):328-36.

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.

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.

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.

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.

Venturi S. Is there a role for iodine in breast diseases? Breast. 2001 Oct;10(5):379-82.

Smyth PP. Role of iodine in antioxidant defence in thyroid and breast disease. Biofactors. 2003;19(3-4):121-30. Review.

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.

Ader DN, Shriver CD, Browne MW. Cyclical mastalgia: premenstrual syndrome or recurrent pain disorder? J Psychosom Obstet Gynaecol. 1999 Dec;20(4):198-202.

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.


ClinicalTrials.gov Identifier:	NCT00237523 History of Changes
Other Study ID Numbers:	SYM1210
Study First Received:	October 7, 2005
Last Updated:	June 15, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Symbollon Pharmaceuticals:


Breast pain Mastalgia Cyclic mastalgia Periodic mastalgia Non-cyclic mastalgia Fibrosis	Nodularity Cysts Fibrocystic breast disease Fibrocystic breast condition Fibocystic breast syndrome

Additional relevant MeSH terms:


Breast Diseases Mastodynia Cystic Fibrosis Fibrocystic Breast Disease Skin Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Pancreatic Diseases Digestive System Diseases	Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016