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

Completed · Phase 2

Conditions studied: Moderate to Severe Cyclic Mastalgia

In brief

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.

Key facts

Study ID

NCT01105793

Run by

FemmePharma Global Healthcare, Inc.

People needed

20

Starts

2010-06-01

Expected to finish

2011-06-01

Last updated by the study team

2011-10-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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