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

Primary Purpose

Fibrocystic Disease of Breast

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
danazol
Placebo
Sponsored by
FemmePharma Global Healthcare, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrocystic Disease of Breast focused on measuring fibrocystic breast disease, fibrocystic disease of breast, breast pain, mastalgia, cyclic mastalgia, cystic breast disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women's Health Research
  • Advanced Clinical Therapeutics, LLC
  • Impact Clinical Trials
  • Women's Health Care at Frost Street
  • Horizons Clinical Research Center, LLC
  • James A Simon, M.D., PC
  • Visions Clinical Research
  • Southeastern Integrated Medical, LLC
  • Palm Beach Research Center
  • Atlanta North Gynecology, PC
  • Women's Health Practice
  • Center for Women's Research
  • Physician's Research Group
  • Kentucky Medical Research Center
  • MedVadis Research Corporation
  • Impact Clinical Trials
  • Delaware Valley OB/GYN and Infertility Group, PC
  • Phoenix OB-GYN Associates
  • UMDNJ Robert Wood Johnson Medica School Women's Health Institute
  • Analgesic Development, Ltd.
  • Rochester Clinical Research, Inc.
  • Columbus Center for Women's Health Research
  • Drexel University College of Medicine
  • Southeastern Clinical Research
  • Jackson Clinic
  • Clinical Trials of Texas, Inc.
  • Seven Oaks Women's Center
  • Salt Lake Research
  • Virginia Women's Center
  • Women's Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

6

Arm Description

Outcomes

Primary Outcome Measures

Subject reported breast pain as measured using a visual analog scale on the subject daily diary

Secondary Outcome Measures

Physician assessment of breast nodularity at each treatment cycle visit

Full Information

First Posted
August 28, 2008
Last Updated
May 25, 2010
Sponsor
FemmePharma Global Healthcare, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00744276
Brief Title
A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
Acronym
FP1198-001
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
FemmePharma Global Healthcare, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrocystic Disease of Breast
Keywords
fibrocystic breast disease, fibrocystic disease of breast, breast pain, mastalgia, cyclic mastalgia, cystic breast disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Placebo Comparator
Arm Title
6
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
danazol
Intervention Description
danazol applied topically once per day for 4 treatment cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo topically applied once daily for 4 treatment cycles
Primary Outcome Measure Information:
Title
Subject reported breast pain as measured using a visual analog scale on the subject daily diary
Time Frame
2 cycles pretreatment plus 4 cycles on treatment
Secondary Outcome Measure Information:
Title
Physician assessment of breast nodularity at each treatment cycle visit
Time Frame
2 cycles pretreatment plus 4 cycles on treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter K. Mays, Ph.D.
Organizational Affiliation
FemmePharma Global Healthcare, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Advanced Clinical Therapeutics, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Women's Health Care at Frost Street
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
James A Simon, M.D., PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Southeastern Integrated Medical, LLC
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta North Gynecology, PC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Center for Women's Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Physician's Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Kentucky Medical Research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
MedVadis Research Corporation
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481-2106
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Delaware Valley OB/GYN and Infertility Group, PC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Phoenix OB-GYN Associates
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
UMDNJ Robert Wood Johnson Medica School Women's Health Institute
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Analgesic Development, Ltd.
City
New York
State/Province
New York
ZIP/Postal Code
10022-1009
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
Southeastern Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seven Oaks Women's Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2890912
Citation
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.
Results Reference
background
PubMed Identifier
3117172
Citation
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.
Results Reference
background
PubMed Identifier
2364227
Citation
Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.
Results Reference
background
PubMed Identifier
2406750
Citation
Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available.
Results Reference
background
PubMed Identifier
15140333
Citation
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.
Results Reference
background
PubMed Identifier
12022387
Citation
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.
Results Reference
background
PubMed Identifier
571588
Citation
Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.
Results Reference
background
PubMed Identifier
3902125
Citation
Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008.
Results Reference
background
PubMed Identifier
1390280
Citation
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.
Results Reference
background
Links:
URL
http://www.GoodBreastHealth.com
Description
General breast health information

Learn more about this trial

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

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