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Fibrocystic Disease of BreastPhase 3NCT00237523

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

A Phase 3 study testing IoGen (molecular iodine) in people with Fibrocystic Disease of Breast and Fibrocystic Changes of Breast, run by Symbollon Pharmaceuticals at 39 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
IoGen (molecular iodine)
How many people
175 participants
Where
39 sitesUnited States
Study dates
Jul 2005to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Visions Clinical Research

    Boynton Beach, Florida, 33437

  • Women's Health Practice

    Champaign, Illinois, 61820

  • Radiant Research

    Cincinnati, Ohio, 45249

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • Expresscare Clinical Research

    Colorado Springs, Colorado, 80909-1691

  • Soapstone Center for Clinical Research

    Decatur, Georgia, 30034

  • Downtown Women's Heath Care

    Denver, Colorado, 80218

  • University of Colorado

    Denver, Colorado, 80262

  • S.H.E. Medical Associates

    Hartford, Connecticut, 06105

  • Penn State The Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Fellows Research Alliance, Inc.

    Hilton Head Island, South Carolina, 29926

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • Physicians Research Group

    Indianapolis, Indiana, 46250

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Missouri

    Kansas City, Missouri, 64108

  • Women's Health Research Center, LLC

    Lawrenceville, New Jersey, 08648

  • Kentucky Medical Research Center

    Lexington, Kentucky, 40504

  • York Clinical Consulting

    Marrero, Louisiana, 70072

  • Miami Research Associates, Inc.

    Miami, Florida, 33143

  • HWC Women's Research Center

    Miamisburg, Ohio, 45342

  • Laurel Creek Research Associates

    Moorestown, New Jersey, 08057

  • LION Research

    Norman, Oklahoma, 73071

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102-1192

  • Women's Health Research

    Phoenix, Arizona, 85015

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • The Medical Group of Northern Nevada

    Reno, Nevada, 89502

  • Fellows Research Alliance, Inc.

    Savannah, Georgia, 31406

  • Women's Clinical Research Center/North Seattle Women's Group

    Seattle, Washington, 98105

  • Department of Ob/Gyn - Women's Health University of Saint Louis

    St Louis, Missouri, 63117

  • Tacoma Women's Specialists

    Tacoma, Washington, 98405

  • Montefiore Medical Center/Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Visions Clinical Research

    Tucson, Arizona, 85712

  • The GYN's Center for Women's Health

    Waterbury, Connecticut, 06708

  • MedVadis Research

    Wellesley, Massachusetts, 02481

  • Greater Hartford Women's Health Associates

    West Hartford, Connecticut, 06117

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Fallon Clinic

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

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

  • 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).
Read the 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.

Being tested
IoGen (molecular iodine)
Keywords
Breast pain, Mastalgia, Cyclic mastalgia, Periodic mastalgia, Non-cyclic mastalgia, Fibrosis, Nodularity, Cysts, Fibrocystic breast disease, Fibrocystic breast condition, Fibocystic breast syndrome
Medical subject headings
Fibrocystic Breast Disease, Pain, Mastodynia, Fibrosis, Cysts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IoGen (molecular iodine)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total clinical breast pain as documented by patient daily diary.

Secondary outcomes (1)

  1. Change in fibrosis based upon breast examination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2005 (estimated)
  2. Study startJul 2005
  3. Study completionMar 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00237523
Sponsor's protocol ID
SYM1210
Status last verified
Jun 2007
First submitted
7 Oct 2005
Last updated
18 Jun 2007
Results posted
No
Data monitoring committee
No

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. doi: 10.1007/s10911-005-5401-5.

    PubMed 16025225

  • 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.

    PubMed 10710195

  • 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.

    PubMed 15239792

  • 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.

    PubMed 8221402

  • 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.

    PubMed 15922087

  • 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.

    PubMed 7577324

  • Thrall KD, Bull RJ, Sauer RL; New Collective Author. 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.

    PubMed 1433379

  • Venturi S. Is there a role for iodine in breast diseases? Breast. 2001 Oct;10(5):379-82. doi: 10.1054/brst.2000.0267.

    PubMed 14965610

  • 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.

    PubMed 14757962

  • 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.

    PubMed 11446156

  • 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.

    PubMed 10656154

  • 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.

    PubMed 9240595

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IoGen (molecular iodine) in people with Fibrocystic Disease of Breast and Fibrocystic Changes of Breast, run by Symbollon Pharmaceuticals at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total clinical breast pain as documented by patient daily diary.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00237523, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2007.

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