An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
1 other identifier
interventional
20
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2010
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedOctober 26, 2011
October 1, 2011
1 year
April 13, 2010
October 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in breast pain
six months
Interventions
High dose FP1198 applied once daily to both breasts for 6 treatment cycles.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Women's Health Care
San Diego, California, 92123, United States
Horizons Clinical Research
Denver, Colorado, 80220, United States
Kentucky Medical Research Center
Lexington, Kentucky, 40504, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 16, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
October 26, 2011
Record last verified: 2011-10