Back to resultsStudy of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
Primary Purpose
Cyclic Breast Pain, Cyclic Mastalgia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Afimoxifene (0.057%) in hydroalcoholic gel
Sponsored by
About this trial
This is an interventional treatment trial for Cyclic Breast Pain, Cyclic Mastalgia focused on measuring breast pain, tenderness, benign breast conditions
Eligibility Criteria
Inclusion Criteria: A woman is eligible for this study if she: is pre-menopausal and at least 18 years of age. has a history of cyclical mastalgia for each of the four months prior to study entry. moderate or severe mastalgia as determined by >40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period. has a history of regular menstrual cycles of 28 plus/minus 3 days. Exclusion Criteria: -
Sites / Locations
Outcomes
Primary Outcome Measures
Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment
Secondary Outcome Measures
Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles
Change from baseline in average VAS pain scores over all scores over all cycles
Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast Pain Chart.
Physician's global assessment of pain.
Physician's clinical evaluation of mastalgia (tenderness determined by palpation).
Physician's clinical evaluation of mastalgia (nodularity).
Patient's global assessment of pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00272714
Brief Title
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
Official Title
A Phase II, Randomized, Double-Blind, Two-Dose, Placebo-Controlled Multicentre Study of 4-Hydroxy Tamoxifen Gel for Cyclical Mastalgia in Otherwise Healthy Pre-Menopausal Women With Regular Menstrual Cycles.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASCEND Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives.
Detailed Description
This study is a Phase II, randomised, double-blind, placebo-controlled, two-dose, multicentre trial of 4-OHT gel in approximately 130 otherwise healthy pre-menopausal women with a history of cyclical mastalgia, peaking during the second half of the menstrual cycle and decreasing significantly with the onset of menstruation, during the four months prior to study entry.
The primary efficacy endpoint in this study is change in change in average pain Visual Analog Scale (VAS) scores for the seven worst pain scores within a cycle, from baseline to the fourth cycle after start of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclic Breast Pain, Cyclic Mastalgia
Keywords
breast pain, tenderness, benign breast conditions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Afimoxifene (0.057%) in hydroalcoholic gel
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment
Secondary Outcome Measure Information:
Title
Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles
Title
Change from baseline in average VAS pain scores over all scores over all cycles
Title
Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast Pain Chart.
Title
Physician's global assessment of pain.
Title
Physician's clinical evaluation of mastalgia (tenderness determined by palpation).
Title
Physician's clinical evaluation of mastalgia (nodularity).
Title
Patient's global assessment of pain.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A woman is eligible for this study if she:
is pre-menopausal and at least 18 years of age.
has a history of cyclical mastalgia for each of the four months prior to study entry.
moderate or severe mastalgia as determined by >40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period.
has a history of regular menstrual cycles of 28 plus/minus 3 days.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Mansel, MD
Organizational Affiliation
University of Wales College of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
We'll reach out to this number within 24 hrs