A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease

NCT00744276 | Completed Phase 2

• 1 other identifier: FP1198-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Fibrocystic Disease of Breast

Keywords

fibrocystic breast disease; fibrocystic disease of breast; breast pain; mastalgia; cyclic mastalgia; cystic breast disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physician assessment of breast nodularity at each treatment cycle visit

  2 cycles pretreatment plus 4 cycles on treatment

Study Arms (6)

1

ACTIVE COMPARATOR

Drug: danazol

2

ACTIVE COMPARATOR

Drug: danazol

3

ACTIVE COMPARATOR

Drug: danazol

4

PLACEBO COMPARATOR

Drug: Placebo

5

PLACEBO COMPARATOR

Drug: Placebo

6

PLACEBO COMPARATOR

Drug: Placebo

Interventions

danazol DRUG

danazol applied topically once per day for 4 treatment cycles

1; 2; 3

Placebo DRUG

placebo topically applied once daily for 4 treatment cycles

4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FemmePharma Global Healthcare, Inc.: lead

Study Sites (30)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Advanced Clinical Therapeutics, LLC

Tucson, Arizona, 85712, United States

Location

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

Women's Health Care at Frost Street

San Diego, California, 92123, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

James A Simon, M.D., PC

Washington D.C., District of Columbia, 20036, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33437, United States

Location

Southeastern Integrated Medical, LLC

Gainsville, Florida, 32607, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Atlanta North Gynecology, PC

Roswell, Georgia, 30075, United States

Location

Women's Health Practice

Champaign, Illinois, 61820, United States

Location

Center for Women's Research

Chicago, Illinois, 60612, United States

Location

Physician's Research Group

Indianapolis, Indiana, 46250, United States

Location

Kentucky Medical Research Center

Lexington, Kentucky, 40504, United States

Location

MedVadis Research Corporation

Wellesley Hills, Massachusetts, 02481-2106, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

Delaware Valley OB/GYN and Infertility Group, PC

Lawrenceville, New Jersey, 08648, United States

Location

Phoenix OB-GYN Associates

Moorestown, New Jersey, 08057, United States

Location

UMDNJ Robert Wood Johnson Medica School Women's Health Institute

New Brunswick, New Jersey, 08901, United States

Location

Analgesic Development, Ltd.

New York, New York, 10022-1009, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102-1192, United States

Location

Southeastern Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Seven Oaks Women's Center

San Antonio, Texas, 78229, United States

Location

Salt Lake Research

Salt Lake City, Utah, 84107, United States

Location

Virginia Women's Center

Richmond, Virginia, 23233, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

Related Publications (9)

• 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.

  PMID: 2890912 BACKGROUND

• 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.

  PMID: 3117172 BACKGROUND

• Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.

  PMID: 2364227 BACKGROUND

• Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available.

  PMID: 2406750 BACKGROUND

• 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.

  PMID: 15140333 BACKGROUND

• 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.

  PMID: 12022387 BACKGROUND

• Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.

  PMID: 571588 BACKGROUND

• Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008.

  PMID: 3902125 BACKGROUND

• 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.

  PMID: 1390280 BACKGROUND

Related Links

• General breast health information

MeSH Terms

Conditions

Fibrocystic Breast Disease; Mastodynia

Interventions

Danazol

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Peter K. Mays, Ph.D.

  FemmePharma Global Healthcare, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: January 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

US (30)