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

June 15, 2007 updated by: Symbollon Pharmaceuticals

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

175

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80909-1691
        • Expresscare Clinical Research
      • Denver, Colorado, United States, 80262
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Downtown Women's Heath Care
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • S.H.E. Medical Associates
      • Waterbury, Connecticut, United States, 06708
        • The GYN's Center for Women's Health
      • West Hartford, Connecticut, United States, 06117
        • Greater Hartford Women's Health Associates
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Visions Clinical Research
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Miami, Florida, United States, 33143
        • Miami Research Associates, Inc.
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance, Inc.
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Physicians Research Group
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Kentucky Medical Research Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • York Clinical Consulting
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481
        • MedVadis Research
      • Worcester, Massachusetts, United States, 01608
        • Fallon Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • University of Missouri
      • Saint Louis, Missouri, United States, 63117
        • Department of Ob/Gyn - Women's Health University of Saint Louis
    • Nevada
      • Reno, Nevada, United States, 89502
        • The Medical Group of Northern Nevada
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Women's Health Research Center, LLC
      • Moorestown, New Jersey, United States, 08057
        • Laurel Creek Research Associates
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center/Albert Einstein College of Medicine
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Radiant Research
      • Miamisburg, Ohio, United States, 45342
        • HWC Women's Research Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Lion Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State The Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Drexel University College of Medicine
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Memorial Hospital of Rhode Island
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Fellows Research Alliance, Inc.
    • Washington
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Center/North Seattle Women's Group
      • Tacoma, Washington, United States, 98405
        • Tacoma Women's Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total clinical breast pain as documented by patient daily diary.

Secondary Outcome Measures

Outcome Measure
Change in fibrosis based upon breast examination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symbollon Pharmaceuticals

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 18, 2007

Last Update Submitted That Met QC Criteria

June 15, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYM1210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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