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Completed

NCT Number: NCT00272714

Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

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.

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Key information

Conditions

Cyclic Breast Pain, Cyclic Mastalgia Mastodynia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Afimoxifene (0.057%) in hydroalcoholic gel

Drug

Primary outcomes

  1. Change in Visual Analog Scale (VAS) scores for the seven worst scores within a cycle, from baseline to the forth cycle after treatment

Secondary outcomes

  1. Change from baseline in average VAS pain scores for the seven worst pain scores within a cycle over all cycles

  2. Change from baseline in average VAS pain scores over all scores over all cycles

  3. Change from baseline in the number of nominal days of breast pain (NDBP) over all cycles using the Cardiff Breast Pain Chart.

  4. Physician's global assessment of pain.

  5. Physician's clinical evaluation of mastalgia (tenderness determined by palpation).

  6. Physician's clinical evaluation of mastalgia (nodularity).

  7. Patient's global assessment of pain.

Sponsors and collaborators

Lead sponsor

ASCEND Therapeutics

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Jan 9, 2006
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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