Table 5. Clinical trials for endometrial hyperplasia.
| ClinicalTrials.gov Identifier (study type) | Hyperplasia grade | Drug | No. of patients (age range, yr) | Phase trial | Study duration | Outcome |
|---|---|---|---|---|---|---|
| NCT01499602 (interventional) | Simple or complex EH without atypia | Levonorgestrel and norethisterone acetate | 120 (40-50) | May 2009-Nov 2011 | Achieve complete regression | |
| NCT00453960 (interventional) | Non atypical EH | Genistein and norethisterone acetate | 59 | II | Jan 2007-Nov 2008 | Recovery from endometrial hyperplasia |
| NCT01234818 (interventional) | EH | LNG-IUD | 80 | II | Nov 2010-Nov 2012 | Endometrial aspiration biopsy shows exacerbation, treatment with LNG-IUD must be stopped and other specific treatment should be initiated. |
| NCT01685762 (interventional) | Asymptomatic EH | Metformin | ~15 (18-75) | 0 | Jul 2012-Apr 2014 | No study results posted on clinicaltrials.gov yet |
| NCT01074892 (interventional) | EH | MPA and levonorgestrel | 170 (30-70) | IV | May 2005-May 2012 | Regression of hyperplasia after 6 months of therapy but recurrence and side effects during 2 year fallow-up treatment |
| NCT00483327 (interventional) | Atypical EH | Megestrol acetate | 31 (>18) | II | Jun 2007-Nov 2013 | Best pathologic response rates |
| NCT01686126 (interventional) | Complex atypia EH | Levonorgestrel and metformin | 165 (>18) | II | Sep 2012-Dec 2014 | Pathological complete response |
| NCT00490087 (interventional) | Atypical endometrial polyps and atypical EH | LNG-IUD | 21 (25-50) | III | Jun 2007-Sep 2011 | Recurrence of polyp in the two groups |
| NCT00883662 (observational) | EH | Levonorgestrel | 2,680 (>18) | - | Jun 2009-Apr 2015 | Patient distribution per indication |
| NCT00919919 (interventional) | EH and EC | progesterone | 60 (45-60) | II | Jun 2009-Nov 2010 | Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3 mm between the two groups. |
| NCT01968317 (interventional) | Atypical EH | Megestrol acetate and metformin | ~150 (18-45) | II | Oct 2013-Apr 2015 | Got pathological response rate |
| NCT00788671 (interventional) | Complex atypical EH | LNG-IUD | ~50 (>18) | II | Nov 2008-Mar 2015 | Complete regression of disease |
| NCT02035787 (interventional) | Complex atypical EH and EC in non-surgical patients | Metformin with LNG-IUD | ~30 (>18) | - | Jan 2014-Jul 2 014 | Percent of individuals achieving complete disease regression as defined by no evidence of microscopic viable hyperplasia or carcinoma on endometrial biopsy after 6 months of treatment compared to a base rate of 50% |
EC, endometrial cancer; EH, endometrial hyperplasia; LNG-IUD, levonorgestrel-impregnated intrauterine device; LNG-IUD, levonorgestrel-impregnated intrauterine system; MPA, medroxy-progesterone acetate.