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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01105793

Enrollment

Registered

2010-04-16

Start date

2010-06-30

Completion date

2011-06-30

Last updated

2011-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Cyclic Mastalgia

Keywords

cyclic mastalgia, cyclic breast pain, fibrocystic breast disease

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.

Interventions

DRUGDanazol

High dose FP1198 applied once daily to both breasts for 6 treatment cycles.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Reduction in breast pain	six months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026