CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 170 enrolled
Drug / intervention
Provera (medroxyprogesterone/progestin) +2 moredrug
Likely dose
Provera (medroxyprogesterone/progestin) 10 mgfrom 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/NCT01074892
NCT01074892Phase 4Completed
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A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia

University Hospital of North Norway·interventional·Posted Feb 24, 2010·Updated Apr 5, 2019

In Brief

A Phase 4 clinical trial evaluating Provera (medroxyprogesterone/progestin), Provera (medroxyprogesterone), and 1 other intervention for Endometrial Hyperplasia. Completed, enrolled 170 participants across 1 site.

Detailed Summary

Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments: 1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle, 2. MPA 10 mg continuously for 6 months, 3. Mirena (Levonorgestrel) impregnated IUD for 6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Hyperplasia
CountriesNorway
CollaboratorsHelse Nord, Norwegian Cancer Society

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2010
Enrollment StartMay 1, 2005
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 16.4 years ago

Interventions

Provera (medroxyprogesterone/progestin)drug

10 mg tablet, 1 tablet per day taken 10 days per month Duration is 6 months

Provera (medroxyprogesterone)drug

10 mg per oral tablet. One tablet per day for 6 months

Mirena (levonorgestrel)device

Inserted in the uterine cavity and kept in situ for 6 months