An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
NCT ID: NCT01105793
Last Updated: 2011-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2010-06-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Danazol
High dose FP1198 applied once daily to both breasts for 6 treatment cycles.
Eligibility Criteria
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Inclusion Criteria
* BMI less than 30
* moderate to severe breast pain associated with the menstrual cycle
* in good general health
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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FemmePharma Global Healthcare, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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FP1198-002
Identifier Type: -
Identifier Source: org_study_id