Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
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| ClinicalTrials.gov Identifier: NCT00237523 |
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Recruitment Status : Unknown
Verified June 2007 by Symbollon Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : October 12, 2005
Last Update Posted : June 18, 2007
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- 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibrocystic Disease of Breast Fibrocystic Changes of Breast Fibrocystic Mastopathy Pain | Drug: IoGen (molecular iodine) | Phase 3 |
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 (Clinical Trial) |
| Estimated Enrollment : | 175 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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 Start Date : | July 2005 |
| Estimated Study Completion Date : | March 2008 |
- Total clinical breast pain as documented by patient daily diary.
- Change in fibrosis based upon breast examination.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237523
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| Study Director: | Julia Kazakhin, M.D. | Symbollon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00237523 |
| Other Study ID Numbers: |
SYM1210 |
| First Posted: | October 12, 2005 Key Record Dates |
| Last Update Posted: | June 18, 2007 |
| Last Verified: | June 2007 |
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Breast pain Mastalgia Cyclic mastalgia Periodic mastalgia Non-cyclic mastalgia Fibrosis |
Nodularity Cysts Fibrocystic breast disease Fibrocystic breast condition Fibocystic breast syndrome |
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Cystic Fibrosis Breast Diseases Fibrocystic Breast Disease Mastodynia Skin Diseases Pain Neurologic Manifestations Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Iodine Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Physiological Effects of Drugs |