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OpenTrials
Completed

NCT Number: NCT01105793

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

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.

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Key information

Conditions

Moderate to Severe Cyclic Mastalgia Breast Diseases Fibrocystic Breast Disease Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women's Health Care, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danazol

Drug

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

Primary outcomes

  1. Reduction in breast pain

    Time frame: six months

Sponsors and collaborators

Lead sponsor

FemmePharma Global Healthcare, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2010
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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