Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

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.

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.

Study Overview

• Status: Completed
• Conditions: Cyclic Breast Pain, Cyclic Mastalgia
• Intervention / Treatment: Drug: Afimoxifene (0.057%) in hydroalcoholic gel

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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.

Collaborators and Investigators

• Sponsor: ASCEND Therapeutics
• Investigators: Principal Investigator: Robert E Mansel, MD, University of Wales College of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: January 5, 2006
• First Submitted That Met QC Criteria: January 5, 2006
• First Posted (Estimated): January 9, 2006

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: breast pain, tenderness, benign breast conditions
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Afimoxifene
• Other Study ID Numbers: 01-4OHT-02