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An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia

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. Identifier: NCT01105793
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : October 26, 2011
Information provided by (Responsible Party):
FemmePharma Global Healthcare, Inc.

Brief Summary:
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.

Condition or disease Intervention/treatment Phase
Moderate to Severe Cyclic Mastalgia Drug: Danazol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

Intervention Details:
  • Drug: Danazol
    High dose FP1198 applied once daily to both breasts for 6 treatment cycles.

Primary Outcome Measures :
  1. Reduction in breast pain [ Time Frame: six months ]

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:   Yes

Inclusion Criteria:

  • menstruating females at least 18 years of age
  • BMI less than 30
  • moderate to severe breast pain associated with the menstrual cycle
  • in good general health

Exclusion Criteria:

  • pregnant within the last 6 months
  • has taken in the last 3 months or currently taking hormonal contraception
  • history of malignancy or currently being treated for cancer of the breast or genital organs
  • 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 identifier (NCT number): NCT01105793

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United States, California
Women's Health Care
San Diego, California, United States, 92123
United States, Colorado
Horizons Clinical Research
Denver, Colorado, United States, 80220
United States, Kentucky
Kentucky Medical Research Center
Lexington, Kentucky, United States, 40504
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
FemmePharma Global Healthcare, Inc.

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Responsible Party: FemmePharma Global Healthcare, Inc. Identifier: NCT01105793    
Other Study ID Numbers: FP1198-002
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011
Keywords provided by FemmePharma Global Healthcare, Inc.:
cyclic mastalgia
cyclic breast pain
fibrocystic breast disease
Additional relevant MeSH terms:
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Neurologic Manifestations
Signs and Symptoms
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs