Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cyclic Breast Pain, Cyclic Mastalgia

Intervention / Treatment
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* Drug: Afimoxifene (0.057%) in hydroalcoholic gel


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Afimoxifene (0.057%) in hydroalcoholic gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast pain, tenderness, benign breast conditions