Back to resultsStudy for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
Primary Purpose
Fibrocystic Disease of Breast, Fibrocystic Changes of Breast, Fibrocystic Mastopathy
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IoGen (molecular iodine)
Sponsored by
About this trial
This is an interventional treatment trial for Fibrocystic Disease of Breast focused on measuring Breast pain, Mastalgia, Cyclic mastalgia, Periodic mastalgia, Non-cyclic mastalgia, Fibrosis, Nodularity, Cysts, Fibrocystic breast disease, Fibrocystic breast condition, Fibocystic breast syndrome
Eligibility 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
Sites / Locations
- Medical Affiliated Research Center, Inc.
- Women's Health Research
- Visions Clinical Research
- Expresscare Clinical Research
- Downtown Women's Heath Care
- University of Colorado
- S.H.E. Medical Associates
- The GYN's Center for Women's Health
- Greater Hartford Women's Health Associates
- Visions Clinical Research
- Women's Medical Research Group, LLC
- Miami Research Associates, Inc.
- Palm Beach Research Center
- Soapstone Center for Clinical Research
- Fellows Research Alliance, Inc.
- Women's Health Practice
- Physicians Research Group
- University of Iowa
- Kentucky Medical Research Center
- York Clinical Consulting
- MedVadis Research
- Fallon Clinic
- University of Missouri
- Department of Ob/Gyn - Women's Health University of Saint Louis
- The Medical Group of Northern Nevada
- Women's Health Research Center, LLC
- Laurel Creek Research Associates
- Montefiore Medical Center/Albert Einstein College of Medicine
- Wake Research Associates, LLC
- Radiant Research
- HWC Women's Research Center
- LION Research
- Oregon Health & Science University
- Penn State The Milton S. Hershey Medical Center
- Drexel University College of Medicine
- Memorial Hospital of Rhode Island
- Fellows Research Alliance, Inc.
- Women's Clinical Research Center/North Seattle Women's Group
- Tacoma Women's Specialists
Outcomes
Primary Outcome Measures
Total clinical breast pain as documented by patient daily diary.
Secondary Outcome Measures
Change in fibrosis based upon breast examination.
Full Information
NCT ID
NCT00237523
First Posted
October 7, 2005
Last Updated
June 15, 2007
Sponsor
Symbollon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00237523
Brief Title
Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Symbollon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrocystic Disease of Breast, Fibrocystic Changes of Breast, Fibrocystic Mastopathy, Pain
Keywords
Breast pain, Mastalgia, Cyclic mastalgia, Periodic mastalgia, Non-cyclic mastalgia, Fibrosis, Nodularity, Cysts, Fibrocystic breast disease, Fibrocystic breast condition, Fibocystic breast syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IoGen (molecular iodine)
Primary Outcome Measure Information:
Title
Total clinical breast pain as documented by patient daily diary.
Secondary Outcome Measure Information:
Title
Change in fibrosis based upon breast examination.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Kazakhin, M.D.
Organizational Affiliation
Symbollon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Visions Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Expresscare Clinical Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909-1691
Country
United States
Facility Name
Downtown Women's Heath Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
S.H.E. Medical Associates
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
The GYN's Center for Women's Health
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Greater Hartford Women's Health Associates
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Miami Research Associates, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Physicians Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kentucky Medical Research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
York Clinical Consulting
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
MedVadis Research
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Fallon Clinic
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
University of Missouri
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Department of Ob/Gyn - Women's Health University of Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
The Medical Group of Northern Nevada
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Women's Health Research Center, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Laurel Creek Research Associates
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Montefiore Medical Center/Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
HWC Women's Research Center
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
LION Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State The Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Women's Clinical Research Center/North Seattle Women's Group
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Tacoma Women's Specialists
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16025225
Citation
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.
Results Reference
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PubMed Identifier
10710195
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. doi: 10.1023/a:1008925301459.
Results Reference
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PubMed Identifier
15239792
Citation
Kessler 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.
Results Reference
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PubMed Identifier
8221402
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.
Results Reference
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PubMed Identifier
15922087
Citation
Garcia-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.
Results Reference
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PubMed Identifier
7577324
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. doi: 10.1007/BF02788999.
Results Reference
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PubMed Identifier
1433379
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. doi: 10.1080/15287399209531682.
Results Reference
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PubMed Identifier
14965610
Citation
Venturi S. Is there a role for iodine in breast diseases? Breast. 2001 Oct;10(5):379-82. doi: 10.1054/brst.2000.0267.
Results Reference
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PubMed Identifier
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Citation
Smyth PP. Role of iodine in antioxidant defence in thyroid and breast disease. Biofactors. 2003;19(3-4):121-30. doi: 10.1002/biof.5520190304.
Results Reference
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PubMed Identifier
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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. doi: 10.3109/01674820109049956.
Results Reference
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PubMed Identifier
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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. doi: 10.3109/01674829909075596.
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PubMed Identifier
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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. doi: 10.1016/s0002-9378(97)70450-2.
Results Reference
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Learn more about this trial
Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
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