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Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

NCT00272714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-08-16

No results posted yet for this study

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.

Conditions

  • Cyclic Breast Pain, Cyclic Mastalgia

Interventions

DRUG

Afimoxifene (0.057%) in hydroalcoholic gel

Sponsors & Collaborators

  • ASCEND Therapeutics

    lead INDUSTRY

Principal Investigators

  • Robert E Mansel, MD · University of Wales College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2004-03-31
Completion
2005-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00272714 on ClinicalTrials.gov