Status:
UNKNOWN
Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
Lead Sponsor:
Symbollon Pharmaceuticals
Conditions:
Fibrocystic Disease of Breast
Fibrocystic Changes of Breast
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00237523
Start Date
July 1 2005
End Date
March 1 2008
Last Update
June 18 2007
Active Locations (39)
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1
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
2
Women's Health Research
Phoenix, Arizona, United States, 85015
3
Visions Clinical Research
Tucson, Arizona, United States, 85712
4
Expresscare Clinical Research
Colorado Springs, Colorado, United States, 80909-1691