Back to resultsAn Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
Primary Purpose
Moderate to Severe Cyclic Mastalgia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Danazol
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Cyclic Mastalgia focused on measuring cyclic mastalgia, cyclic breast pain, fibrocystic breast disease
Eligibility Criteria
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
Sites / Locations
- Women's Health Care
- Horizons Clinical Research
- Kentucky Medical Research Center
- Salt Lake Research
Outcomes
Primary Outcome Measures
Reduction in breast pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01105793
First Posted
April 13, 2010
Last Updated
October 25, 2011
Sponsor
FemmePharma Global Healthcare, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01105793
Brief Title
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Cyclic Mastalgia
Keywords
cyclic mastalgia, cyclic breast pain, fibrocystic breast disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Danazol
Intervention Description
High dose FP1198 applied once daily to both breasts for 6 treatment cycles.
Primary Outcome Measure Information:
Title
Reduction in breast pain
Time Frame
six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Women's Health Care
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Horizons Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Kentucky Medical Research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
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