An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
Phase 2
Completed
- Conditions
- Moderate to Severe Cyclic Mastalgia
- Registration Number
- NCT01105793
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reduction in breast pain six months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Women's Health Care
🇺🇸San Diego, California, United States
Horizons Clinical Research
🇺🇸Denver, Colorado, United States
Kentucky Medical Research Center
🇺🇸Lexington, Kentucky, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States