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

• Sponsor: FemmePharma Global Healthcare, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01105793
• Collaborator: (none)
• Enrollment: 20
• Locations: 4
• Duration (Months): 12
• Patients Per Site: 5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Cyclic Mastalgia	Drug: Danazol	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Outcome Measures

Primary Outcome Measures

1. Reduction in breast pain [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Health Care	San Diego	California	United States	92123
2	Horizons Clinical Research	Denver	Colorado	United States	80220
3	Kentucky Medical Research Center	Lexington	Kentucky	United States	40504
4	Salt Lake Research	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• FemmePharma Global Healthcare, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FemmePharma Global Healthcare, Inc.
• ClinicalTrials.gov Identifier: NCT01105793
• Other Study ID Numbers: FP1198-002
• First Posted: Apr 16, 2010
• Last Update Posted: Oct 26, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by FemmePharma Global Healthcare, Inc.: cyclic mastalgia; cyclic breast pain; fibrocystic breast disease
• Additional relevant MeSH terms: Mastodynia; Danazol

Study Results

No Results Posted as of Oct 26, 2011