CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 69 enrolled
Drug / intervention
Laboratory Biomarker Analysis +2 moreother
Likely dose
Not stated in 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/NCT00788671
NCT00788671Phase 2Active
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A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma

M.D. Anderson Cancer Center·interventional·Posted Nov 11, 2008·Updated Aug 15, 2025

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Levonorgestrel-Releasing Intrauterine System, and 1 other intervention for Atypical Endometrial Hyperplasia and 4 related conditions. Active but no longer recruiting, targeting 69 participants across 7 sites.

Detailed Summary

This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Active
20092010201120122013201420152016201720182019202020212022202320242025202620272028
First PostedNov 11, 2008
Enrollment StartNov 3, 2008
Primary CompletionJun 10, 2016
Study CompletionNov 30, 2027
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 17.6 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Levonorgestrel-Releasing Intrauterine Systemdevice

Undergo placement of a levonorgestrel-releasing intrauterine system

Quality-of-Life Assessmentother

Ancillary studies