Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

Cyclic Breast Pain, Cyclic Mastalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272714
• Other study ID #: 01-4OHT-02
• Status: Completed
• Phase: Phase 2
• Start date: March 2003
• Est. completion date: April 2005

Study information

• Verified date: July 2013
• Source: ASCEND Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: April 2005
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Cyclic Breast Pain, Cyclic Mastalgia
• Mastodynia

Intervention

Drug:
• Afimoxifene (0.057%) in hydroalcoholic gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ASCEND Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment
Secondary	Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles
Secondary	Change from baseline in average VAS pain scores over all scores over all cycles
Secondary	Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast Pain Chart.
Secondary	Physician's global assessment of pain.
Secondary	Physician's clinical evaluation of mastalgia (tenderness determined by palpation).
Secondary	Physician's clinical evaluation of mastalgia (nodularity).
Secondary	Patient's global assessment of pain.