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

Status unconfirmed · Phase 3

Conditions studied: Fibrocystic Disease of Breast, Fibrocystic Changes of Breast, Fibrocystic Mastopathy, Pain

In brief

* 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).

Key facts

Study ID

NCT00237523

Run by

Symbollon Pharmaceuticals

People needed

175

Starts

2005-07-01

Expected to finish

2008-03-01

Last updated by the study team

2007-06-18

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• Women's Health Research — Phoenix, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• Expresscare Clinical Research — Colorado Springs, Colorado, 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
• The GYN's Center for Women's Health — Waterbury, Connecticut, United States
• Greater Hartford Women's Health Associates — West Hartford, Connecticut, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Miami Research Associates, Inc. — Miami, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Soapstone Center for Clinical Research — Decatur, Georgia, United States
• Fellows Research Alliance, Inc. — Savannah, Georgia, United States
• Women's Health Practice — Champaign, Illinois, United States
• Physicians Research Group — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Kentucky Medical Research Center — Lexington, Kentucky, United States
• York Clinical Consulting — Marrero, Louisiana, United States
• MedVadis Research — Wellesley, Massachusetts, United States
• Fallon Clinic — Worcester, Massachusetts, United States
• University of Missouri — Kansas City, Missouri, United States
• Department of Ob/Gyn - Women's Health University of Saint Louis — St Louis, Missouri, United States
• The Medical Group of Northern Nevada — Reno, Nevada, United States

Full record on ClinicalTrials.gov

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