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

Sponsor

FemmePharma Global Healthcare, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00744276

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibrocystic Disease of Breast	Drug: danazol Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: danazol danazol applied topically once per day for 4 treatment cycles
Active Comparator: 2	Drug: danazol danazol applied topically once per day for 4 treatment cycles
Active Comparator: 3	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
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

Outcome Measures

Primary Outcome Measures

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

Physician assessment of breast nodularity at each treatment cycle visit [2 cycles pretreatment plus 4 cycles on treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

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