A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease (FP1198-001)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Evaluation of the Use of Topically Administered Danazol Versus Placebo in Subjects With Pain Associated With Fibrocystic Breast Disease

The purpose of this study is to determine the safety of three doses of topically applied danazol compared to placebo in subjects with pain associated with fibrocystic breast disease and to determine the appropriate clinical dose for future studies.

Study Overview

• Status: Completed
• Conditions: Fibrocystic Disease of Breast
• Intervention / Treatment: Drug: danazol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research
    • Tucson, Arizona, United States, 85712
      • Advanced Clinical Therapeutics, LLC
  • California
    • Beverly Hills, California, United States, 90211
      • Impact Clinical Trials
    • San Diego, California, United States, 92123
      • Women's Health Care at Frost Street
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • James A Simon, M.D., PC
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Visions Clinical Research
    • Gainsville, Florida, United States, 32607
      • Southeastern Integrated Medical, LLC
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Roswell, Georgia, United States, 30075
      • Atlanta North Gynecology, PC
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice
    • Chicago, Illinois, United States, 60612
      • Center For Women's Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Physician's Research Group
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Kentucky Medical Research Center
  • Massachusetts
    • Wellesley Hills, Massachusetts, United States, 02481-2106
      • MedVadis Research Corporation
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Impact Clinical Trials
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Delaware Valley OB/GYN and Infertility Group, PC
    • Moorestown, New Jersey, United States, 08057
      • Phoenix Ob-Gyn Associates
    • New Brunswick, New Jersey, United States, 08901
      • UMDNJ Robert Wood Johnson Medica School Women's Health Institute
  • New York
    • New York, New York, United States, 10022-1009
      • Analgesic Development, Ltd.
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Columbus Center for Women's Health Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Drexel University College of Medicine
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Southeastern Clinical Research
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Seven Oaks Women's Center
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Salt Lake Research
  • Virginia
    • Richmond, Virginia, United States, 23233
      • Virginia Women's Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Menstruating females at least 18 years of age
• Has moderate to severe breast pain associated with cyclical fibrocystic breast disease
• Is in good general health

Exclusion Criteria:

• Pregnant within the past 6 months or lactating
• History of malignancy or currently being treated for cancer of the breast or genital organs
• Has taken within the past 3 months or is currently taking hormonal contraception
• Has any condition for which an androgen or steroid is contraindicated
• Has had breast implants or breast reduction surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: danazol; danazol applied topically once per day for 4 treatment cycles
Active Comparator: 1	Drug: danazol; danazol applied topically once per day for 4 treatment cycles
Placebo Comparator: 4	Drug: Placebo; placebo topically applied once daily for 4 treatment cycles
Active Comparator: 3	Drug: danazol; danazol applied topically once per day for 4 treatment cycles
Placebo Comparator: 5	Drug: Placebo; placebo topically applied once daily for 4 treatment cycles
Placebo Comparator: 6	Drug: Placebo; placebo topically applied once daily for 4 treatment cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject reported breast pain as measured using a visual analog scale on the subject daily diary	2 cycles pretreatment plus 4 cycles on treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Physician assessment of breast nodularity at each treatment cycle visit	2 cycles pretreatment plus 4 cycles on treatment

Collaborators and Investigators

• Sponsor: FemmePharma Global Healthcare, Inc.
• Investigators: Study Director: Peter K. Mays, Ph.D., FemmePharma Global Healthcare, Inc.

Publications and helpful links

General Publications

• Vaidyanathan L, Barnard K, Elnicki DM. Benign breast disease: when to treat, when to reassure, when to refer. Cleve Clin J Med. 2002 May;69(5):425-32. doi: 10.3949/ccjm.69.5.425.
• Hughes LE, Mansel RE, Webster DJ. Aberrations of normal development and involution (ANDI): a new perspective on pathogenesis and nomenclature of benign breast disorders. Lancet. 1987 Dec 5;2(8571):1316-9. doi: 10.1016/s0140-6736(87)91204-9.
• Panahy C, Puddefoot JR, Anderson E, Vinson GP, Berry CL, Turner MJ, Brown CL, Goode AW. Effects of danazol on incidence of progesterone and oestrogen receptors in benign breast disease. Br Med J (Clin Res Ed). 1987 Aug 22;295(6596):464-6. doi: 10.1136/bmj.295.6596.464.
• Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.
• Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available.
• Gumm R, Cunnick GH, Mokbel K. Evidence for the management of mastalgia. Curr Med Res Opin. 2004 May;20(5):681-4. doi: 10.1185/030079904125003377.
• Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.
• Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008.
• Gledhill JM, Barker S, Wanless C, Hinson JP, Puddefoot JR, Panahy C, Goode AW, Vinson GP. Progesterone receptor induction by danazol in cultured cancer cells and the rat uterus. J Steroid Biochem Mol Biol. 1992 Oct;43(4):289-96. doi: 10.1016/0960-0760(92)90163-d.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 28, 2008
• First Submitted That Met QC Criteria: August 28, 2008
• First Posted (Estimate): August 29, 2008

Study Record Updates

• Last Update Posted (Estimate): May 27, 2010
• Last Update Submitted That Met QC Criteria: May 25, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: breast pain; cyclic mastalgia; fibrocystic breast disease; mastalgia; fibrocystic disease of breast; cystic breast disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Breast Diseases; Fibrocystic Breast Disease; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Danazol
• Other Study ID Numbers: FP1198-001