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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00744276
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
FemmePharma Global Healthcare, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases
Drug Information available for: Danazol

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




Primary Outcome Measures :
  1. 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 Measures :
  1. Physician assessment of breast nodularity at each treatment cycle visit [ Time Frame: 2 cycles pretreatment plus 4 cycles on treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744276


Locations
Show Show 30 study locations
Sponsors and Collaborators
FemmePharma Global Healthcare, Inc.
Investigators
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Study Director: Peter K. Mays, Ph.D. FemmePharma Global Healthcare, Inc.

Additional Information:
Publications:
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Responsible Party: Peter K. Mays, Ph.D. / Vice President, Pharmaceutical Development, FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00744276    
Other Study ID Numbers: FP1198-001
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010
Keywords provided by FemmePharma Global Healthcare, Inc.:
fibrocystic breast disease
fibrocystic disease of breast
breast pain
mastalgia
cyclic mastalgia
cystic breast disease
Additional relevant MeSH terms:
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Danazol
Cystic Fibrosis
Breast Diseases
Fibrocystic Breast Disease
Skin Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs