Trial reportAsian Pacific journal of cancer prevention : APJCP2021
A Randomized Clinical Trial of Levonorgestrel Intrauterine System with or without Metformin for Treatment of Endometrial Hyperplasia without Atypia in Indian Women.
Trial report in Asian Pacific journal of cancer prevention : APJCP, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Metformin for endometrial hyperplasia.The Cochrane database of systematic reviews · 2024Pooled it
- Progestin plus metformin improves outcomes in patients with endometrial hyperplasia and early endometrial cancer more than progestin alone: a meta-analysis.Frontiers in endocrinology · 2023Pooled it
- Metformin combined with progesterone improves efficacy and reduces adverse reactions in early endometrial cancer.American journal of translational research · 2026Article
- Obesity management in the setting of endometrial cancer and hyperplasia: A narrative review.Gynecologic oncology reports · 2025Review
- Comparative effects of different treatments based on the levonorgestrel intrauterine system in endometrial carcinoma and endometrial hyperplasia patients: a network meta-analysis.Archives of gynecology and obstetrics · 2024Review
- Prediction of complete regression in fertility-sparing patients with endometrial cancer and apical hyperplasia: the GLOBAL model in a large Chinese cohort.Journal of translational medicine · 2024Article
- Metformin as an Adjunct to Progestin Therapy in Endometrial Hyperplasia and Early-Stage Endometrial Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Acta medica Philippina · 2024Article
- Weight-Loss and Metformin-Use Improve the Reversal Rate in Patients with Endometrial Hyperplasia.International journal of women's health · 2024Article
- Efficacy of Oral Medications or Intrauterine Device-Delivered Progestin in Patients with Endometrial Hyperplasia with or without Atypia: A Network Meta-Analysis.Journal of clinical medicine · 2023Review
- Levonorgestrel-releasing intrauterine system treatment for endometrial hyperplasia and early endometrial cancer: a systematic review.Therapeutic advances in reproductive healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEndometrial cancer is the second most frequent genital malignancy in women, which is showing a constant rise all over world. Endometrial hyperplasia is the precursor of endometrial cancer. Levonorgestrel intrauterine system is the first line management in patients with endometrial hyperplasia without atypia. Metformin has shown to reverse endometrial hyperplasia, but its effectiveness and safety in endometrial hyperplasia is uncertain.
objectiveTo compare the efficacy in terms of histopathological response, clinical response and safety at the end of 6 months in patients with endometrial hyperplasia without atypia managed with Levonorgestrel intrauterine system alone versus patients managed with Levonorgestrel intrauterine system plus metformin.
methodsThe randomized control trial was conducted on 51 cases of endometrial hyperplasia without atypia. Twenty-five subjects were prescribed metformin 500mg twice daily with Levonorgestrel intrauterine system and 26 subjects, with Levonorgestrel intrauterine system only for 6 months. At the end of 6 months, endometrial sampling was performed for histopathological response.
resultsClinical response was observed in 23 of 25 subjects in metformin group and 22 of 24 in Levonorgestrel only group. The metformin group responded significantly with amenorrhea (p= 0.0053), while Levonorgestrel only group responded with regular cycles (p=0.027). At the end of study, of 46 subjects available for histopathological evaluation, 100% subjects in metformin group and 95.45% in Levonorgestrel only group (p=0.47826) showed complete response. The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
conclusionNo significant difference in regression of endometrial hyperplasia was observed on adjunctive use of metformin but a significant reduction in BMI was observed. Use of metformin in obese patients may improve the treatment response.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.