NCT00272714

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

August 16, 2023

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

January 5, 2006

Last Update Submit

August 15, 2023

Conditions

Cyclic Breast Pain, Cyclic Mastalgia

Keywords

breast pain, tenderness, benign breast conditions

Outcome Measures

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 (7)

  • 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).

  • +2 more secondary outcomes

Interventions

Afimoxifene (0.057%) in hydroalcoholic gelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mastodynia

Interventions

afimoxifene

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert E Mansel, MD

    University of Wales College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

March 1, 2003

Primary Completion

March 1, 2004

Study Completion

April 1, 2005

Last Updated

August 16, 2023

Record last verified: 2013-07