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

FemmePharma

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Cyclic Mastalgia

Treatments: Drug: Danazol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105793

FP1198-002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)