CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,000 enrolled
Drug / intervention
500 mg of depot hydroxy-progesteronedrug
Likely dose
500 mg of depot hydroxy-progesteronefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00123669
NCT00123669Phase 3Completed
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The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial

Tata Memorial Hospital·interventional·Posted Jul 25, 2005·Updated Jul 22, 2020

In Brief

A Phase 3 clinical trial evaluating 500 mg of depot hydroxy-progesterone for Breast Neoplasms. Completed, enrolled 1,000 participants across 1 site.

Detailed Summary

The purpose of this study is to test the effect of primary progesterone on overall and disease free survival in women with operable breast cancer. The study addresses two issues related to breast cancer surgery: * Circulating progesterone at the time of surgery might counteract the detrimental effect of estrogen on survival of women with operable breast cancer. * Events at the time of surgery may have an impact on the natural history of breast cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesIndia
CollaboratorsMinistry of Science and Technology, India

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2005
Enrollment StartOct 1, 1997
Primary CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 22.7 yearsPosted 20.9 years ago

Interventions

500 mg of depot hydroxy-progesteronedrug

An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.