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

NCT00237523 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2007-06-18

No results posted yet for this study

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 one breast.
* Euthyroid with no prior history of thyroid disease.
* Six months of daily therapy with molecular iodine.
* Placebo controlled vs active (1:1).

Conditions

  • Fibrocystic Disease of Breast
  • Fibrocystic Changes of Breast
  • Fibrocystic Mastopathy
  • Pain

Interventions

DRUG

IoGen (molecular iodine)

Sponsors & Collaborators

  • Symbollon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Julia Kazakhin, M.D. · Symbollon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00237523 on ClinicalTrials.gov