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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Symbollon Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Symbollon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00237523
First received: October 7, 2005
Last updated: June 15, 2007
Last verified: June 2007
  Purpose
  • 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 Intervention Phase
Fibrocystic Disease of Breast
Fibrocystic Changes of Breast
Fibrocystic Mastopathy
Pain
Drug: IoGen (molecular iodine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Symbollon Pharmaceuticals:

Primary Outcome Measures:
  • Total clinical breast pain as documented by patient daily diary.

Secondary Outcome Measures:
  • Change in fibrosis based upon breast examination.

Estimated Enrollment: 175
Study Start Date: July 2005
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237523

  Show 39 Study Locations
Sponsors and Collaborators
Symbollon Pharmaceuticals
Investigators
Study Director: Julia Kazakhin, M.D. Symbollon Pharmaceuticals, Inc.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00237523     History of Changes
Other Study ID Numbers: SYM1210
Study First Received: October 7, 2005
Last Updated: June 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Symbollon Pharmaceuticals:
Breast pain
Mastalgia
Cyclic mastalgia
Periodic mastalgia
Non-cyclic mastalgia
Fibrosis
Nodularity
Cysts
Fibrocystic breast disease
Fibrocystic breast condition
Fibocystic breast syndrome

Additional relevant MeSH terms:
Mastodynia
Cystic Fibrosis
Fibrocystic Breast Disease
Breast Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Skin Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014