Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier:
NCT01105793
First received: April 13, 2010
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Moderate to Severe Cyclic Mastalgia
 Drug: Danazol
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Breast Diseases
Drug Information available for: Danazol
U.S. FDA Resources

Further study details as provided by FemmePharma Global Healthcare, Inc.:

Primary Outcome Measures:
  • Reduction in breast pain [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Danazol
    High dose FP1198 applied once daily to both breasts for 6 treatment cycles.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105793

Locations
United States, California
Women's Health Care
San Diego, California, United States, 92123
United States, Colorado
Horizons Clinical Research
Denver, Colorado, United States, 80220
United States, Kentucky
Kentucky Medical Research Center
Lexington, Kentucky, United States, 40504
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
FemmePharma Global Healthcare, Inc.
  More Information

No publications provided

Responsible Party: FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT01105793     History of Changes
Other Study ID Numbers: FP1198-002
Study First Received: April 13, 2010
Last Updated: October 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by FemmePharma Global Healthcare, Inc.:
cyclic mastalgia
cyclic breast pain
fibrocystic breast disease

Additional relevant MeSH terms:
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013