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

Moderate to Severe Cyclic Mastalgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105793
• Other study ID #: FP1198-002
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2010
• Last updated: October 25, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2011
• Source: FemmePharma Global Healthcare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mastodynia
• Moderate to Severe Cyclic Mastalgia

Intervention

Drug:
• Danazol
High dose FP1198 applied once daily to both breasts for 6 treatment cycles.

Locations

Country	Name	City	State
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	Women's Health Care	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
FemmePharma Global Healthcare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in breast pain		six months	No